Implant inserter

ABSTRACT

A system for implant delivery includes an implant and an inserter. The implant includes a body that extends between first and second ends. The implant includes retainers extending outwardly from the first and second ends. The retainers are received in corresponding jaws of the inserter. When the implant is connected to the inserter and the inserter is actuated, the implant elastically deforms.

PRIORITY CLAIM

The present application is a continuation of U.S. application Ser. No. 17/704,274, filed Mar. 25, 2022, which is a continuation of U.S. application Ser. No. 16/076,607, filed Aug. 8, 2018, now U.S. Pat. No. 11,284,886, issued Mar. 29, 2022, which is a National Phase of International Application No. PCT/US2017/016931, filed Feb. 8, 2017, which claims priority to U.S. Provisional Application Nos. 62/292,823, filed Feb. 8, 2016; and 62/355,276, filed Jun. 27, 2016. The entire contents of each of which are incorporated herein by reference and relied upon.

TECHNICAL FIELD

The present disclosure is made in the context of an inserter for a compression bone staple. However, one of skill in the art will appreciate that the disclosed technology is broadly applicable outside this context to implants that are movable between a free state and an elastically deformed state.

BACKGROUND

Staples of various designs are used for fixation in surgical procedures. In such procedures, two human body parts, e.g. bones, on either side of an interface, are joined together by drilling parallel holes in the body parts on either side of the interface and inserting the legs of a staple into the holes. The legs of the staple are substantially parallel to each other when they are inserted into the holes, but the staple is constructed so that after the staple has been implanted, the ends of the legs converge forcefully towards each other, and thus substantially immobilize the interface. Continuing compression of the body parts has additional benefits, for example continuing compression of bones at the interface promotes bone regrowth. The known surgical staples are composed of a shape memory metal (e.g. a nickel titanium alloy) or an elastic polymeric material, for example polyetherether ketone (PEEK). The known procedures for inserting staples into bones are complicated and expensive.

SUMMARY

The various systems and methods of the present technology have been developed in response to the present state of the art, and in particular, in response to the problems and needs in the art that have not yet been fully solved by currently available systems with implants and inserters.

In an aspect of the technology, a system includes: an implant including a body, a left retainer, and a right retainer, wherein the body extends between a left end and a right end to establish a longitudinal direction of the body, wherein the left retainer protrudes from the left end of the body, wherein the right retainer protrudes from the right end of the body; and an inserter releasably connectable to the implant, the inserter including a left connection, a right connection, and an intermediate connection between the left and right connections; wherein when the inserter is connected to the implant, the left connection engages the left retainer, the right connection engages the right retainer, and the intermediate connection is adjacent to the body; wherein when the inserter is connected to the implant, the system is movable between a free state and an actuated state, wherein in the free state the body is undeformed by the inserter, wherein in the actuated state the body is elastically deformed by pressure from the intermediate connection acting against resistance from the left and right connections.

Various embodiments of this aspect of the technology may include any or all of the following characteristics. The left and right retainers extend along the longitudinal direction of the body. The body extends between a front side and an opposite back side to establish a front to back direction of the body, wherein the left and right retainers extend along the front to back direction. The body extends between a body lower surface and an opposite body upper surface, wherein the left retainer extends between a left lower surface and an opposite left upper surface, wherein the right retainer extends between a right lower surface and an opposite right upper surface, wherein the body upper surface and the left and right lower surfaces are on the same side of the body lower surface. When the inserter is connected to the implant, the body upper surface and the entire inserter are on the same side of the body lower surface. The body lower surface is a bone facing surface. The left connection is a left jaw, wherein the right connection is a right jaw, wherein the intermediate connection is a junction; wherein when the inserter is connected to the implant, the left jaw engages under the left retainer, the right jaw engages under the right retainer, and the junction is adjacent to the body.

In another aspect of the technology, a system includes: an implant including a body, a left retainer, and a right retainer, wherein the body includes a bone contacting surface, wherein the body extends between a left end and a right end to establish a longitudinal direction of the body, wherein the left retainer protrudes from the left end of the body, wherein the right retainer protrudes from the right end of the body; and an inserter releasably connectable to the implant, the inserter including a left connection, a right connection, and an intermediate connection between the left and right connections; wherein when the inserter is connected to the implant, the left connection engages the left retainer, the right connection engages the right retainer, and the intermediate connection is adjacent to the body, wherein the left and right retainers and the entire inserter are all on the same side of the bone contacting surface; wherein when the inserter is connected to the implant, the system is movable between a free state and an actuated state, wherein in the free state the body is undeformed by the inserter, wherein in the actuated state the body is elastically deformed by pressure from the intermediate connection acting against resistance from the left and right connections.

Various embodiments of this aspect of the technology may include any or all of the following characteristics. The left and right retainers extend along the longitudinal direction of the body. The body extends between a front side and an opposite back side to establish a front to back direction of the body, wherein the left and right retainers extend along the front to back direction. The body includes an upper surface opposite the bone contacting surface, wherein the left retainer extends between a left lower surface and an opposite left upper surface, wherein the right retainer extends between a right lower surface and an opposite right upper surface, wherein the upper surface of the body and the left and right lower surfaces are on the same side of the bone contacting surface. The left connection is a left hook, wherein the right connection is a right hook, wherein the intermediate connection is a junction; wherein when the inserter is connected to the implant, the left hook engages under the left retainer, the right hook engages under the right retainer, and the junction is adjacent to the body.

In yet another aspect of the technology, a system includes: a bone staple including a bridge, a left leg, a right leg, a left retainer, and a right retainer, wherein the bridge extends between a left end and a right end to establish a longitudinal direction of the bridge, wherein the left leg includes a left proximal end that is attached to the left end of the bridge, wherein the left leg terminates in a left distal end opposite the bridge, wherein the right leg includes a right proximal end that is attached to the right end of the bridge, wherein the right leg terminates in a right distal end opposite the bridge, wherein the right leg extends beside the left leg, wherein the left and right proximal ends are separated by a first distance, wherein the left retainer is attached to and extends from the left end of the bridge, wherein the right retainer is attached to and extends from the right end of the bridge, wherein the bone staple is movable between a staple free state and an elastically deformed state, wherein when the bone staple is in the staple free state, the staple is undeformed and the left and right distal ends are separated by a second distance which is less than the first distance, wherein when the bone staple is in the elastically deformed state, the left and right distal ends are separated by a third distance which is greater than the second distance; and an inserter releasably connectable to the bone staple, the inserter including a left connector, a right connector, and an intermediate connector, wherein the left connector faces the right connector, wherein the intermediate connector is between the left and right connectors, wherein the inserter is movable between an inserter free state and an actuated state; wherein when the inserter in the inserter free state is connected to the bone staple in the staple free state, the left connector engages the left retainer, the right connector engages the right retainer, and the intermediate connector is adjacent to the bridge, between the left and right ends of the bridge, and opposite the left and right legs; wherein when the inserter in the actuated state is connected to the bone staple in the elastically deformed state, the left connector engages the left retainer, the right connector engages the right retainer, and the intermediate connector presses against the bridge between the left and right ends of the bridge and opposite the left and right legs.

Various embodiments of this aspect of the technology may include any or all of the following characteristics. The left and right retainers extend along the longitudinal direction.

The bridge extends between a front side and an opposite back side to establish a front to back direction of the bridge, wherein the left and right retainers extend along the front to back direction.

The bridge extends between a bridge lower surface and an opposite bridge upper surface, wherein the left retainer extends between a left lower surface and an opposite left upper surface, wherein the right retainer extends between a right lower surface and an opposite right upper surface, wherein the bridge upper surface and the left and right lower surfaces are on the same side of the bridge lower surface. When the inserter is connected to the bone staple, the bridge upper surface and the entire inserter are on the same side of the bridge lower surface. The bridge lower surface is a bone contacting surface. The third distance is equal to the first distance. The third distance is greater than the first distance.

These and other features and advantages of the present technology will become more fully apparent from the following description and appended claims, or may be learned by the practice of the technology as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments of the technology will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. Understanding that these drawings depict only exemplary embodiments and are, therefore, not to be considered limiting of the scope of the technology, the exemplary embodiments will be described with additional specificity and detail through use of the accompanying drawings in which:

FIG. 1 is a front view of a delivery device;

FIG. 2 is a side view of the delivery device of FIG. 1 ;

FIG. 3 is a front view of another delivery device;

FIG. 4 is a side view of the delivery device of FIG. 3 ;

FIG. 5 is a perspective view of yet another delivery device;

FIG. 6A is a perspective view of yet another delivery device; FIG. 6B is another perspective view of the delivery device of FIG. 6A from a different direction; FIG. 6C is an exploded perspective view of the delivery device of FIG. 6A; and FIG. 6D is another exploded perspective view of the delivery device of FIG. 6A from a different direction;

FIG. 7 is a perspective view of yet another delivery device;

FIG. 8 is a front view of yet another delivery device;

FIG. 9 is a front view of a staple;

FIG. 10 is a perspective view of the staple of FIG. 9 ;

FIG. 11 is a perspective view of another staple;

FIG. 12 is an exploded perspective view of the staple of FIG. 11 ;

FIG. 13A is a perspective view of yet another staple; FIG. 13B is a front view of the staple of FIG. 13A; and FIG. 13C is a cross sectional view of a base member of the staple of FIG. 13A taken along section line 13C-13C of FIG. 13B;

FIG. 14A is a perspective view of yet another staple; FIG. 14B is a front view of the staple of FIG. 14A; and FIG. 14C is a cross sectional view of the staple of FIG. 14A taken along section line 14C-14C of FIG. 14B;

FIG. 15 is a perspective view of yet another staple; and

FIG. 16 is a perspective view of yet another staple;

FIG. 17A is a detail perspective view of a distal portion of a system with an implant coupled to an inserter; FIG. 17B is a detail side view of a distal portion of the system of FIG. 17A; and FIG. 17C is a perspective view of the system of FIG. 17A;

FIG. 18A is a front view of an implant for use in the system of FIG. 17A; and FIG. 18B is a perspective view of the implant of FIG. 18A;

FIG. 19A is a front view of another implant for use in the system of FIG. 17A; and FIG. 19B is a perspective view of the implant of FIG. 18A;

FIG. 20A is an exploded perspective view of the inserter of FIG. 17A; and FIG. 20B is another exploded perspective view of the inserter of FIG. 17A from a different direction;

FIG. 21A is a perspective view of another system with yet another implant coupled to another inserter; and FIG. 21B is a detail front view of a distal portion of the system of FIG. 21A;

FIG. 22A is a detail perspective view of a distal portion of a body of the inserter of FIG. 21A; and FIG. 22B is another detail perspective view of the distal portion of the body of FIG. 22A from a different direction;

FIG. 23 is a perspective view of a control member of the inserter of FIG. 21A;

FIG. 24 is a perspective view of left and right capture members of the inserter of FIG. 21A; and

FIG. 25A is a perspective view of the implant of FIG. 21A; FIG. 25B is an exploded perspective view of the implant of FIG. 21A; FIG. 25C is a front view of the implant of FIG. 21A; and FIG. 25D is a side view of the implant of FIG. 21A.

DETAILED DESCRIPTION

Exemplary embodiments of the technology will be best understood by reference to the drawings, wherein like parts are designated by like numerals throughout. It will be readily understood that the components of the technology, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments of the apparatus, system, and method is not intended to limit the scope of the invention, as claimed, but is merely representative of exemplary embodiments of the technology.

The phrases “connected to,” “coupled to” and “in communication with” refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be functionally coupled to each other even though they are not in direct contact with each other. The term “abutting” refers to items that are in direct physical contact with each other, although the items may not necessarily be attached together. The phrase “fluid communication” refers to two features that are connected such that a fluid within one feature is able to pass into the other feature.

The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments. While the various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated.

Standard medical planes of reference and descriptive terminology are employed in this specification. A sagittal plane divides a body into right and left portions. A mid-sagittal plane divides the body into bilaterally symmetric right and left halves. A coronal plane divides a body into anterior and posterior portions. A transverse plane divides a body into superior and inferior portions. The sagittal, coronal, and transverse planes are mutually perpendicular. Anterior means toward the front of the body. Posterior means toward the back of the body. Superior means toward the head. Inferior means toward the feet. Medial means toward the midline of the body. Lateral means away from the midline of the body. Axial means toward a central axis of the body. Abaxial means away from a central axis of the body. Ipsilateral means on the same side of the body. Contralateral means on the opposite side of the body. These descriptive terms may be applied to an animate or inanimate body.

In this specification, “elastic” is defined as behavior of a material or a part that returns to its undeformed state when applied forces are removed. “Elastic zone” is defined as a region of a stress-strain curve for a material in which the material returns to its undeformed state when applied forces are removed. The elastic zone is between zero stress, zero strain and the yield point of the material.

The numbers (dimensions) in this specification are to be construed with the latitude appropriate to their context and expression. Each number (dimension) is subject to variation which depends on the accuracy with which it can be measured by methods conventionally used by those skilled in the art as of the filing date of this disclosure. “About,” “substantially,” and other such terms in this specification are to be construed according to these principles.

Referring to FIGS. 1 and 2 , a delivery device 100 includes a staple 102 and an inserter 104. In this example, the staple 102 and inserter 104 are integrally formed as a monolithic delivery device 100. The staple 102 and inserter 104 may be made of a polymer such as PEEK or a polymeric composition based upon PEEK. Alternatively, the staple 102 may be made of a first polymer and the inserter 104 may be made of a second polymer which is different from the first polymer. In this arrangement, the staple 102 and the inserter 104 may be coupled together to form the delivery device 100, for example by bonding, for example by melt bonding. The staple 102 and inserter 104 may also be made of metal, such as a nickel titanium alloy.

The staple 102 includes a bridge 106 which extends longitudinally between a left end 108 and a right end 110. The staple 102 includes a left leg 112 and a right leg 114. A proximal end 116 of the left leg 112 is attached to the left end 108 of the bridge 106. The left leg 112 terminates in a distal end 118, which is a free end opposite the bridge 106. A proximal end 120 of the right leg 114 is attached to the right end 110 of the bridge 106. The right leg 114 terminates in a distal end 122, which is a free end opposite the bridge 106. The facing surfaces of the legs 112, 114 include teeth 124. When the staple 102 is implanted, the teeth 124 help to retain the staple 102 in the desired position. The teeth 124 may be on any or all sides of the legs 112, 114.

The staple 102 is shown in its free state, in which the staple 102 is not elastically or plastically deflected or deformed. The free state may be referred to as the closed state. In one example of the free state, the staple 102 experiences no external loads, other than gravity perhaps. However, in the free state, the staple 102 may experience loads that are below a threshold for elastic or plastic deflection or deformation. In the free state, the distal ends 118, 122 of the legs 112, 114 are closer together than the proximal ends 116, 120 so that the legs 112, 114 converge as they extend away from the bridge 106.

The staple 102 may be moved between the free state and an elastically deformed state by elastically deforming some or all of the staple 102. For example, elastically deflecting or pressing on the bridge 106 so that it is straight or curves down between the legs 112, 114 causes the distal ends 118, 122 to spread apart. The legs 112, 114 may spread apart in the elastically deformed state so as to become parallel. The elastically deformed state may be referred to as the open state. The elastically deformed state may be suitable for implantation of the staple 102 and may thus be referred to as an insertion state or an implantation state.

The inserter 104 may be referred to as a delivery member. The inserter 104 includes a left body 126 and a right body 128 which in this example is a mirror image of the left body 126 across a first plane of symmetry 125, which is shown edge on in FIG. 1 and is thus represented by a dashed line 125. The left body 126 includes a distal portion 130 and a proximal portion 132. The right body 128 includes a distal portion 134 and a proximal portion 136. The left distal portion 130 is connected to the left end 108 of the bridge 106 by a left connection 138. The right distal portion 134 is connected to the right end 110 of the bridge 106 by a right connection 140. The distal portions 130, 134 are connected to the bridge 106 solely by the connections 138, 140, which are at or close to the ends 108, 110. The connections 138, 140 may be ruptured after the staple 102 has been implanted, to disconnect the inserter 104 from the staple 102. For example, the connections 138, 140 may be ruptured by use of a surgical wire cutter, scissors, a scalpel, or a rupturing instrument specifically designed to correspond to the connections 138, 140, or by being manually broken. After rupture, the bridge 106 may include residue from the ruptured connections 138, 140. The distal portions 130, 134 extend along and above the bridge 106 and are joined together at a central junction 142 which is shown in the vicinity of the plane 125. The central junction 142 is not secured to the bridge 106, but can be brought into contact with the bridge 106 as discussed below.

The inserter 104 is shown in its free state, in which the inserter 104 is not elastically or plastically deflected or deformed. In one example of the free state, the inserter 104 experiences no external loads, other than gravity perhaps. However, in the free state, the inserter 104 may experience loads that are below a threshold for elastic or plastic deflection or deformation. In the free state, the proximal portions 132, 136 are separated by a gap 144 having a free state dimension 146. In the free state, the central junction 142 may contact the bridge 106, or the central junction 142 may optionally be separated from the bridge by a gap 148.

The inserter 104 may be moved between the free state and an actuated state by moving or pressing the proximal portions 132, 136 towards each other and towards the plane 125, thereby changing the shape of the inserter 104. This can be done manually, for example with an index finger on the left proximal portion 132 and a thumb on the right proximal portion 136. In other examples, the proximal portions 132, 136 may be moved away from each other or otherwise moved relative to each other, to move the inserter 104 between the free state and the actuated state. The actuated state may be referred to as a compressed state, an insertion state, or an implantation state. When the inserter 104 is moved from the free state to the actuated state, the gap 144 becomes smaller, the bodies 126, 128 pivot about the connections 138, 140 respectively, and the central junction 142 presses against the bridge 106, thus causing the staple 102 to move from the free state to the elastically deformed state. Conversely, as the inserter 104 is moved from the actuated state to the free state, the staple 102 moves from the elastically deformed state to the free state.

When the inserter 104 is in the actuated state and the staple 102 is in the elastically deformed state, the delivery device 100 may be used to implant the staple 102. After the staple 102 has been implanted, the connections 138, 140 may be ruptured. The inserter 104 may then be removed from the implantation site, leaving the staple 102 in place.

The height of the delivery device 100 may be 40-80 mm. The height of the staple 102 may be 18-25 mm, preferably about 21 mm. The height of the bridge 106 may be 2.5-4 mm, preferably about 3 mm. The height of the inserter 104 may be 25-40 mm, preferably about 30 mm. These heights are taken parallel to line 125 in FIG. 1 . The width of the delivery device 100 may be 18-30 mm. The width of the bridge 106 may be 20-30 mm, preferably about 25 mm. These widths are taken perpendicular to line 125 in FIG. 1 . The width of the bridge 106 may also be referred to as the length of the bridge 106. The free state dimension 146 of the gap 144 may be 15-30 mm, preferably about 20 mm. The dimension 146 is taken perpendicular to line 125 in FIG. 1 . The thickness of the delivery device 100 may be 3-8 mm. The inserter 104, the bridge 106, and the proximal ends 116, 120 of the legs 112, 114 may be 4-7 mm thick, preferably about 5 mm thick. The distal ends 118, 122 of the legs 112, 114 may be thinner, for example 2-4 mm thick, preferably about 2.75 mm thick. These thicknesses are taken when the delivery device 100 is viewed from the side as shown in FIG. 2 . Thickness may also be referred to as depth. The bridge 106, the legs 112, 114, and the inserter 104 may lie between two parallel planes.

Methods of manufacturing the delivery device 100 may include: (1) forming the staple 102 and the inserter 104 as a monolithic article by shaping a single material in a single step; (2) forming the staple 102 from a first material; forming the inserter 104 from a second material that may be the same as or different from the first material; and securing the staple 102 and the inserter 104 together; (3) forming the staple 102 from the first material; and forming the inserter 104 from the second material in contact with the previously formed staple 102; or (4) forming the inserter 104 from the second material; and forming the staple 102 from the first material in contact with the previously formed inserter 104. Shaping may involve molding, cutting, additive manufacturing processes, or the like. Molding may involve injection molding, insert molding, over molding, or the like. Cutting may involve laser cutting. Additive manufacturing may involve three-dimensional printing.

A method of using the delivery device 100 may include any or all of the following steps in any order: making a first hole in a first body part; making a second hole in a second body part; moving the inserter 104 from the free state to the actuated state; moving the staple 102 from the free state to the elastically deformed state; moving the legs 112, 114 to be parallel; inserting the left leg 112 into the first hole; inserting the right leg 114 into the second hole; seating the bridge 106 against the first and/or second body part; moving the inserter 104 from the actuated state toward the free state; moving the staple 102 from the elastically deformed state toward the free state; moving the legs 112, 114 toward a converging state; rupturing the connections 138, 140; and removing the inserter 104 from the implantation site, leaving the staple 102 in place.

Making the first and/or second holes may involve drilling the first and/or second holes, optionally using a drill guide. The first hole may be substantially parallel to the second hole. The first and/or second body parts may be bone. Moving the inserter 104 from the free state to the actuated state may occur substantially in advance of a surgical procedure in which the delivery device 100 is used or immediately before inserting the legs 112, 114 into the first and second holes, respectively. Moving the inserter 104 from the free state to the actuated state may cause the staple 102 to move from the free state to the elastically deformed state. When the staple 102 is in the elastically deformed state, the left leg 112 may be substantially parallel to the right leg 114. Inserting the legs 112, 114 into the first and second holes, respectively, may involve partially or completely provisionally inserting the legs 112, 114 into the first and second holes and partially or completely withdrawing the legs 112, 114 from the first and second holes, while the inserter 104 is in the actuated state, and/or while the staple 102 is in the elastically deformed state, and/or before rupturing the connections 138, 140. Seating the bridge 106 against the first and/or second body part may involve direct contact between a bone facing side of the bridge 106 (a surface of the bridge 106 that faces towards the distal ends 118, 122) and a surface of the first and/or second body part. Moving the inserter 104 from the actuated state toward the free state may involve releasing pressure on the proximal portions 132, 136 acting to urge the proximal portions 132, 136 towards each other and towards the plane 125. Moving the inserter 104 from the actuated state toward the free state may cause the staple 102 to move from the elastically deformed state toward the free state. The inserter 104 and the staple 102 may relax toward their respective free states, but under certain circumstances they may not completely achieve their free states. Rupturing the connections may occur while the inserter 104 is in the actuated state and/or while the staple 102 is in the elastically deformed state. Rupturing the connections may cause the staple 102 to move from the elastically deformed state toward the free state.

Referring to FIGS. 3 and 4 , another delivery device 300 includes a staple 302 and an inserter 304. Delivery device 300 may be similar to delivery device 100. In this example, the staple 302 and inserter 304 are integrally formed as a monolithic delivery device 300. The staple 302 and inserter 304 may be made of a polymer such as PEEK or a polymeric composition based upon PEEK. Alternatively, the staple 302 may be made of a first polymer and the inserter 304 may be made of a second polymer which is different from the first polymer. In this arrangement, the staple 302 and the inserter 304 may be coupled together to form the delivery device 300, for example by bonding, for example by melt bonding. The staple 302 and the inserter 304 may also be made of metal.

The staple 302 includes a bridge 306 which extends longitudinally between a left end 308 and a right end 310. The staple 302 includes a left leg 312 and a right leg 314. A proximal end 316 of the left leg 312 is attached to the left end 308 of the bridge 306. The left leg 312 terminates in a distal end 318, which is a free end opposite the bridge 306. A proximal end 320 of the right leg 314 is attached to the right end 310 of the bridge 306. The right leg 314 terminates in a distal end 322, which is a free end opposite the bridge 306. The facing surfaces of the legs 312, 314 include teeth 324. When the staple 302 is implanted, the teeth 324 help to retain the staple 302 in the desired position. The teeth 324 may be on any or all sides of the legs 312, 314.

The staple 302 includes a reinforcing member 350 which may be metal, for example a nickel titanium alloy. The reinforcing member 350 may have a rectangular, square, or round cross section. The reinforcing member 350 may be easily fabricated from ribbon stock, square wire stock, or round wire stock. The reinforcing member 350 extends along the bridge 306 and optionally part way along the legs 312, 314. The reinforcing member 350 may extend along 50-90% of the length of each leg 312, 314. The reinforcing member 350 may be partially or wholly embedded in the bridge 306 and the legs 312, 314 of the staple 302, or it may be attached to the surface of the bridge 306 and the legs 312, 314. The staple 302 may include a base member 352, which in this example is the polymer portion of the staple 302 other than the reinforcing member 350. The base member 352 may be easily molded with the desired three-dimensional characteristics for the staple 302. The base member 352 may include a channel into which the reinforcing member 350 is fitted. The staple 302 may be referred to as a hybrid staple 302 because it includes a polymer base member 352 and a metal reinforcing member 350.

The staple 302 is shown in its free state, in which the staple 302 is not elastically or plastically deflected or deformed. The free state may be referred to as the closed state. In one example of the free state, the staple 302 experiences no external loads, other than gravity perhaps. However, in the free state, the staple 302 may experience loads that are below a threshold for elastic or plastic deflection or deformation. In the free state, the distal ends 318, 322 of the legs 312, 314 are closer together than the proximal ends 316, 320 so that the legs 312, 314 converge as they extend away from the bridge 306. The reinforcing member 350 may maintain the legs 312, 314 in the free state.

The staple 302 may be moved between the free state and an elastically deformed state by elastically deforming some or all of the staple 302, including corresponding portions of the reinforcing member 350. For example, elastically deflecting or pressing on the bridge 306 so that it is straight or curves down between the legs 312, 314 causes the distal ends 318, 322 to spread apart. The legs 312, 314 may spread apart in the elastically deformed state so as to become parallel. The elastically deformed state may be referred to as the open state. The elastically deformed state may be suitable for implantation of the staple 302 and may thus be referred to as an insertion state or an implantation state.

The inserter 304 may be referred to as a delivery member. The inserter 304 includes a left body 326 and a right body 328 which in this example is a mirror image of the left body 326 across a first plane of symmetry 325, which is shown edge on in FIG. 3 and is thus represented by a dashed line 325. The left body 326 includes a distal portion 330 and a proximal portion 332. The right body 328 includes a distal portion 334 and a proximal portion 336. The left distal portion 330 is connected to the left end 308 of the bridge 306 by a left connection 338. The right distal portion 334 is connected to the right end 310 of the bridge 306 by a right connection 340. The distal portions 330, 334 are connected to the bridge 306 solely by the connections 338, 340, which are at or close to the ends 308, 310. The connections 338, 340 may be ruptured after the staple 302 has been implanted, to disconnect the inserter 304 from the staple 302. For example, the connections 338, 340 may be ruptured by use of a surgical wire cutter, scissors, a scalpel, or a rupturing instrument specifically designed to correspond to the connections 338, 340, or by being manually broken. After rupture, the bridge 306 may include residue from the ruptured connections 338, 340. The distal portions 330, 334 extend along and above the bridge 306 and are joined together at a central junction 342 which is shown in the vicinity of the plane 325. The central junction 342 is not secured to the bridge 306, but can be brought into contact with the bridge 306 as discussed below.

The inserter 304 is shown in its free state, in which the inserter 304 is not elastically or plastically deflected or deformed. In one example of the free state, the inserter 304 experiences no external loads, other than gravity perhaps. However, in the free state, the inserter 304 may experience loads that are below a threshold for elastic or plastic deflection or deformation. In the free state, the proximal portions 332, 336 are separated by a gap 344 having a free state dimension 346. In the free state, the central junction 342 may contact the bridge 306, or the central junction 342 may optionally be separated from the bridge by a gap 348.

The inserter 304 may be moved between the free state and an actuated state by moving or pressing the proximal portions 332, 336 towards each other and towards the plane 325, thereby changing the shape of the inserter 304. This can be done manually, for example with an index finger on the left proximal portion 332 and a thumb on the right proximal portion 336. In other examples, the proximal portions 332, 336 may be moved away from each other or otherwise moved relative to each other, to move the inserter 304 between the free state and the actuated state. The actuated state may be referred to as a compressed state, an insertion state, or an implantation state. When the inserter 304 is moved from the free state to the actuated state, the gap 344 becomes smaller, the bodies 326, 328 pivot about the connections 338, 340 respectively, and the central junction 342 presses against the bridge 306, thus causing the staple 302 to move from the free state to the elastically deformed state. Conversely, as the inserter 304 is moved from the actuated state to the free state, the staple 302 moves from the elastically deformed state to the free state. The reinforcing member 350 may urge the base member 352 toward the free state and may increase the post-implantation compressive force of the staple 302 compared to unreinforced polymer staples.

When the inserter 304 is in the actuated state and the staple 302 is in the elastically deformed state, the delivery device 300 may be used to implant the staple 302. After the staple 302 has been implanted, the connections 338, 340 may be ruptured. The inserter 304 may then be removed from the implantation site, leaving the staple 302 in place.

Methods of manufacturing the delivery device 300 may include: (1) forming the base member 352 and the inserter 304 as a monolithic article by shaping a single material in a single step; forming the reinforcing member 350 of metal, preferably a nickel titanium alloy; and connecting the reinforcing member 350 to the base member 352; (2) forming the base member 352 from a first material; forming the inserter 304 from a second material that may be the same as or different from the first material; forming the reinforcing member 350 from a third material that is metal, preferably a nickel titanium alloy; and securing the base member 352, the inserter 304, and the reinforcing member 350 together; (3) forming the reinforcing member 350 from the third material; forming the base member 352 from the first material in contact with the previously formed reinforcing member 350 to form the staple 302; and forming the inserter 304 from the second material in contact with the previously formed staple 302; or (4) forming the inserter 304 from the second material; forming the reinforcing member 350 from the third material; and forming the base member 352 from the first material in contact with the previously formed inserter 304 and reinforcing member 350. The steps of forming the base member 352 and the inserter 304 as a monolithic article and connecting the reinforcing member 350 may occur simultaneously, for example as an overmolding or insert molding operation. Shaping may involve molding, cutting, additive manufacturing processes, or the like. Molding may involve injection molding, insert molding, over molding, or the like. Cutting may involve laser cutting. Additive manufacturing may involve three-dimensional printing.

A method of using the delivery device 300 may include any or all of the following steps in any order: making a first hole in a first body part; making a second hole in a second body part; moving the inserter 304 from the free state to the actuated state; moving the staple 302 from the free state to the elastically deformed state; moving the legs 312, 314 to be parallel; inserting the left leg 312 into the first hole; inserting the right leg 314 into the second hole; seating the bridge 306 against the first and/or second body part; moving the inserter 304 from the actuated state toward the free state; moving the staple 302 from the elastically deformed state toward the free state; moving the legs 312, 314 toward a converging state; rupturing the connections 338, 340; and removing the inserter 304 from the implantation site, leaving the staple 302 in place.

Making the first and/or second holes may involve drilling the first and/or second holes, optionally using a drill guide. The first hole may be substantially parallel to the second hole. The first and/or second body parts may be bone. Moving the inserter 304 from the free state to the actuated state may occur substantially in advance of a surgical procedure in which the delivery device 300 is used or immediately before inserting the legs 312, 314 into the first and second holes, respectively. Moving the inserter 304 from the free state to the actuated state may cause the staple 302 to move from the free state to the elastically deformed state. When the staple 302 is in the elastically deformed state, the left leg 312 may be substantially parallel to the right leg 314. Inserting the legs 312, 314 into the first and second holes, respectively, may involve partially or completely provisionally inserting the legs 312, 314 into the first and second holes and partially or completely withdrawing the legs 312, 314 from the first and second holes, while the inserter 304 is in the actuated state, and/or while the staple 302 is in the elastically deformed state, and/or before rupturing the connections 338, 340. Seating the bridge 306 against the first and/or second body part may involve direct contact between a bone facing side of the bridge 306 (a surface of the bridge 306 that faces towards the distal ends 318, 322) and a surface of the first and/or second body part. Moving the inserter 304 from the actuated state toward the free state may involve releasing pressure on the proximal portions 332, 336 acting to urge the proximal portions 332, 336 towards each other and towards the plane 325. Moving the inserter 304 from the actuated state toward the free state may cause the staple 302 to move from the elastically deformed state toward the free state. The inserter 304 and the staple 302 may relax toward their respective free states, but under certain circumstances they may not completely achieve their free states. Rupturing the connections may occur while the inserter 304 is in the actuated state and/or while the staple 302 is in the elastically deformed state. Rupturing the connections may cause the staple 302 to move from the elastically deformed state toward the free state.

Referring to FIG. 5 , yet another delivery device 500 includes a staple 502 and an inserter 504. In this example, the staple 502 and inserter 504 are integrally formed as a monolithic delivery device 500. The staple 502 and inserter 504 may be made of a polymer such as PEEK or a polymeric composition based upon PEEK. Alternatively, the staple 502 may be made of a first polymer and the inserter 504 may be made of a second polymer which is different from the first polymer. In this arrangement, the staple 502 and the inserter 504 may be coupled together to form the delivery device 500, for example by bonding, for example by melt bonding. The staple 502 and inserter 504 may also be made of metal, such as a nickel titanium alloy.

The staple 502 includes a bridge 506 which extends longitudinally between a left end 508 and a right end 510. The staple 502 includes a left leg 512 and a right leg 514. A proximal end 516 of the left leg 512 is attached to the left end 508 of the bridge 506. The left leg 512 terminates in a distal end 518, which is a free end opposite the bridge 506. A proximal end 520 of the right leg 514 is attached to the right end 510 of the bridge 506. The right leg 514 terminates in a distal end 522, which is a free end opposite the bridge 506. The facing surfaces of the legs 512, 514 include teeth 524. When the staple 502 is implanted, the teeth 524 help to retain the staple 502 in the desired position. The teeth 524 may be on any or all sides of the legs 512, 514.

The staple 502 is shown in its free state, in which the staple 502 is not elastically or plastically deflected or deformed. The free state may be referred to as the closed state. In one example of the free state, the staple 502 experiences no external loads, other than gravity perhaps. However, in the free state, the staple 502 may experience loads that are below a threshold for elastic or plastic deflection or deformation. In the free state, the distal ends 518, 522 of the legs 512, 514 are closer together than the proximal ends 516, 520 so that the legs 512, 514 converge as they extend away from the bridge 506.

The staple 502 may be moved between the free state and an elastically deformed state by elastically deforming some or all of the staple 502. For example, elastically deflecting or pressing on the bridge 506 so that it is straight or curves down between the legs 512, 514 causes the distal ends 518, 522 to spread apart. The legs 512, 514 may spread apart in the elastically deformed state so as to become parallel. The elastically deformed state may be referred to as the open state. The elastically deformed state may be suitable for implantation of the staple 502 and may thus be referred to as an insertion state or an implantation state.

The staple 502 may be modified to include a reinforcing member as described for staple 302. In this situation, the staple 502 may be referred to as a hybrid staple 502 because it includes a polymer base member and a metal reinforcing member.

The inserter 504 may be referred to as a delivery member. The inserter 504 includes a left body 526 and a right body 528 which in this example is a mirror image of the left body 526 across a first plane of symmetry 525. The left body 526 includes a distal portion 530 and a proximal portion 532. The right body 528 includes a distal portion 534 and a proximal portion 536. The left distal portion 530 is connected to the left end 508 of the bridge 506 by a left connection 538 which is noticeably thinner than the connections 138, 338. The left connection 538 includes a notch 550 at the connection with the left end 508 of the bridge 506. The notch 550 may be present on one or both sides of the left connection 538 to direct and control rupture of the left connection 538. The example shows notches 550 on both sides of the left connection 538. The right distal portion 534 is connected to the right end 510 of the bridge 506 by a thin elongated right connection 540 that includes notches 552 on both sides at the connection with the right end 510 of the bridge 506. The distal portions 530, 534 are connected to the bridge 506 solely by the connections 538, 540, which are at or close to the ends 508, 510. The connections 538, 540 may be ruptured after the staple 502 has been implanted, to disconnect the inserter 504 from the staple 502. For example, the connections 538, 540 may be ruptured at the notches 550, 552 by use of a surgical wire cutter, scissors, a scalpel, or a rupturing instrument specifically designed to correspond to the connections 538, 540, or by being manually broken. After rupture, the bridge 506 may include residue from the ruptured connections 538, 540. Preferably, the notches 550, 552 are positioned so that little or no residue protrudes from the bridge. The distal portions 530, 534 extend along and above the bridge 506 and are joined together at a central junction 542 which is shown in the vicinity of the plane 525. The central junction 542 is not secured to the bridge 506, but can be brought into contact with the bridge 506 as discussed below.

The inserter 504 includes a flex bridge 554 which extends between the bodies 526, 528. The flex bridge 554 is curved or bent so that the flex bridge 554 is deformable, preferably elastically deformable. The flex bridge 554 maintains the bodies 526, 528 in a desired spatial configuration. The flex bridge 554 may be integrally formed with the inserter 504, or it may be a separate part that is attached between the bodies 526, 528.

The inserter 504 is shown in its free state, in which the inserter 504 is not elastically or plastically deflected or deformed. In one example of the free state, the inserter 504 experiences no external loads, other than gravity perhaps. However, in the free state, the inserter 504 may experience loads that are below a threshold for elastic or plastic deflection or deformation. In the free state, the proximal portions 532, 536 are separated by a gap 544 having a free state dimension 546. In the free state, the central junction 542 may contact the bridge 506, or the central junction 542 may optionally be separated from the bridge by a gap 548.

The inserter 504 may be moved between the free state and an actuated state by moving or pressing the proximal portions 532, 536 towards each other and towards the plane 525, thereby changing the shape of the inserter 504. This can be done manually, for example with an index finger on the left proximal portion 532 and a thumb on the right proximal portion 536. In other examples, the proximal portions 532, 536 may be moved away from each other or otherwise moved relative to each other, to move the inserter 504 between the free state and the actuated state. The actuated state may be referred to as a compressed state, an insertion state, or an implantation state. When the inserter 504 is moved from the free state to the actuated state, the gap 544 becomes smaller, the bodies 526, 528 pivot about the connections 538, 540 respectively, the flex bridge 554 deforms, and the central junction 542 presses against the bridge 506, thus causing the staple 502 to move from the free state to the elastically deformed state. Conversely, as the inserter 504 is moved from the actuated state to the free state, the staple 502 moves from the elastically deformed state to the free state.

When the inserter 504 is in the actuated state and the staple 502 is in the elastically deformed state, the delivery device 500 may be used to implant the staple 502. After the staple 502 has been implanted, the connections 538, 540 may be ruptured. The inserter 504 may then be removed from the implantation site, leaving the staple 502 in place.

Methods of manufacturing the delivery device 500 may include: (1) forming the staple 502 and the inserter 504 as a monolithic article by shaping a single material in a single step; (2) forming the staple 502 from a first material; forming the inserter 504 from a second material that may be the same as or different from the first material; and securing the staple 502 and the inserter 504 together; (3) forming the staple 502 from the first material; and forming the inserter 504 from the second material in contact with the previously formed staple 502; or (4) forming the inserter 504 from the second material; and forming the staple 502 from the first material in contact with the previously formed inserter 504. Shaping may involve molding, cutting, additive manufacturing processes, or the like. Molding may involve injection molding, insert molding, over molding, or the like. Cutting may involve laser cutting. Additive manufacturing may involve three-dimensional printing.

A method of using the delivery device 500 may include any or all of the following steps in any order: making a first hole in a first body part; making a second hole in a second body part; moving the inserter 504 from the free state to the actuated state; moving the staple 502 from the free state to the elastically deformed state; moving the legs 512, 514 to be parallel; inserting the left leg 512 into the first hole; inserting the right leg 514 into the second hole; seating the bridge 506 against the first and/or second body part; moving the inserter 504 from the actuated state toward the free state; moving the staple 502 from the elastically deformed state toward the free state; moving the legs 512, 514 toward a converging state; rupturing the connections 538, 540; and removing the inserter 504 from the implantation site, leaving the staple 502 in place.

Making the first and/or second holes may involve drilling the first and/or second holes, optionally using a drill guide. The first hole may be substantially parallel to the second hole. The first and/or second body parts may be bone. Moving the inserter 504 from the free state to the actuated state may occur substantially in advance of a surgical procedure in which the delivery device 500 is used or immediately before inserting the legs 512, 514 into the first and second holes, respectively. Moving the inserter 504 from the free state to the actuated state may cause the staple 502 to move from the free state to the elastically deformed state. When the staple 502 is in the elastically deformed state, the left leg 512 may be substantially parallel to the right leg 514. Inserting the legs 512, 514 into the first and second holes, respectively, may involve partially or completely provisionally inserting the legs 512, 514 into the first and second holes and partially or completely withdrawing the legs 512, 514 from the first and second holes, while the inserter 504 is in the actuated state, and/or while the staple 502 is in the elastically deformed state, and/or before rupturing the connections 538, 540. Seating the bridge 506 against the first and/or second body part may involve direct contact between a bone facing side of the bridge 506 (a surface of the bridge 506 that faces towards the distal ends 518, 522) and a surface of the first and/or second body part. Moving the inserter 504 from the actuated state toward the free state may involve releasing pressure on the proximal portions 532, 536 acting to urge the proximal portions 532, 536 towards each other and towards the plane 525. Moving the inserter 504 from the actuated state toward the free state may cause the staple 502 to move from the elastically deformed state toward the free state. The inserter 504 and the staple 502 may relax toward their respective free states, but under certain circumstances they may not completely achieve their free states. Rupturing the connections may occur while the inserter 504 is in the actuated state and/or while the staple 502 is in the elastically deformed state. Rupturing the connections may cause the staple 502 to move from the elastically deformed state toward the free state.

Referring to FIGS. 6A-6D, yet another delivery device 600 includes a staple 602 and an inserter 604. The delivery device 600 may be similar to the delivery device 500. However, in this example, the staple 602 and inserter 604 are formed separately and coupled together. The staple 602 may be made of a metal, such as a nickel titanium alloy, or a polymer such as PEEK or a polymeric composition based upon PEEK. The inserter 604 may be made of a metal or a polymer.

The staple 602 includes a bridge 606 which extends longitudinally between a left end 608 and a right end 610. The staple 602 includes a left leg 612 and a right leg 614. A proximal end 616 of the left leg 612 is attached to the left end 608 of the bridge 606. The left leg 612 terminates in a distal end 618, which is a free end opposite the bridge 606. A proximal end 620 of the right leg 614 is attached to the right end 610 of the bridge 606. The right leg 614 terminates in a distal end 622, which is a free end opposite the bridge 606. The facing surfaces of the legs 612, 614 include teeth 624. When the staple 602 is implanted, the teeth 624 help to retain the staple 602 in the desired position. The teeth 624 may be on any or all sides of the legs 612, 614.

The staple 602 includes left and right securing members 656, 658 which function as left and right connections 638, 640 very similar to the connections 538, 540. The left securing member 656 extends from the left end 608 of the bridge 606 opposite the left leg 612, and terminates in a left locking member 660. The right securing member 658 extends from the right end 610 of the bridge 606 opposite the right leg 614, and terminates in a right locking member 662. Each locking member 660, 662 is bilaterally enlarged in the left-right direction relative to its respective securing member 656, 658, so that bilateral undercuts are formed at the transition between the locking member and the securing member. The locking members 660, 662 are shaped like arrowheads in this example. There are notches 650 on both sides of the left securing member 656 at the connection with the left end 608 of the bridge 606. There are notches 652 on both sides of the right securing member 658 at the connection with the right end 610 of the bridge 606.

The staple 602 is shown in its free state, in which the staple 602 is not elastically or plastically deflected or deformed. The free state may be referred to as the closed state. In one example of the free state, the staple 602 experiences no external loads, other than gravity perhaps. However, in the free state, the staple 602 may experience loads that are below a threshold for elastic or plastic deflection or deformation. In the free state, the distal ends 618, 622 of the legs 612, 614 are closer together than the proximal ends 616, 620 so that the legs 612, 614 converge as they extend away from the bridge 606.

The staple 602 may be moved between the free state and an elastically deformed state by elastically deforming some or all of the staple 602. For example, elastically deflecting or pressing on the bridge 606 so that it is straight or curves down between the legs 612, 614 causes the distal ends 618, 622 to spread apart. The legs 612, 614 may spread apart in the elastically deformed state so as to become parallel. The elastically deformed state may be referred to as the open state. The elastically deformed state may be suitable for implantation of the staple 602 and may thus be referred to as an insertion state or an implantation state.

The staple 602 may be modified to include a reinforcing member as described herein. In this situation, the staple 602 may be referred to as a hybrid staple 602 because it includes a polymer base member and a metal reinforcing member. The staple 602 may be replaced by staple 802, described below.

The inserter 604 may be referred to as a delivery member. The inserter 604 includes a left body 626 and a right body 628 which in this example is a mirror image of the left body 626 across a first plane of symmetry 625 (FIG. 6A). The left body 626 includes a distal portion 630 and a proximal portion 632. The right body 628 includes a distal portion 634 and a proximal portion 636.

The left distal portion 630 includes a left recess 664 formed in a distal side of the body 626. The left recess 664 includes a wide portion 668 that is shaped to receive the left locking member 660 and a narrow portion 670 that is shaped to receive at least a portion of the left securing member 656. The right distal portion 634 includes a right recess 672 formed in a distal side of the body 628. The right recess 672 includes a wide portion 674 that is shaped to receive the right locking member 662 and a narrow portion 676 that is shaped to receive at least a portion of the right securing member 658. The recesses 664, 672 may be referred to as formations or pockets. The recesses 664, 672 engage the bilateral undercuts so that tension may be applied to the securing members 656,658 by the inserter 604. The recesses 664, 672 may receive the securing members 656, 658 and locking members 660, 662 with a close fit or an interference fit, and may even be formed around the securing members 656, 658 and locking members 660, 662 (or vice versa) in a molding operation.

The left distal portion 630 is connected to the left end 608 of the bridge 606 by the left connection 638 (securing member 656 and locking member 660) received in the recess 664. The right distal portion 634 is connected to the right end 610 of the bridge 606 by the right connection 640 received in the recess 672. The connections 638, 640 may slide into engagement with the recesses 664, 672 from the front or back of the inserter 604. An adhesive may be used. After insertion, the locking members 660, 662 cannot be easily removed from the inserter 604 until the surgeon decides that the staple 602 should be implanted. The distal portions 630, 634 are connected to the bridge 606 solely by the connections 638, 640, which are at or close to the ends 608, 610. The connections 638, 640 may be ruptured after the staple 602 has been implanted, to disconnect the inserter 604 from the staple 602. For example, the connections 638, 640 may be ruptured at the notches 650, 652 by use of a surgical wire cutter, scissors, a scalpel, or a rupturing instrument specifically designed to correspond to the connections 638, 640, or by being manually broken. After rupture, the bridge 606 may include residue from the ruptured connections 638, 640, such as residue from the ruptured securing members 656, 658. Preferably, the notches 650, 652 are positioned so that little or no residue protrudes from the bridge. The distal portions 630, 634 extend along and above the bridge 606 and are joined together at a central junction 642 which is shown in the vicinity of the plane 625. The central junction 642 is not secured to the bridge 606, but can be brought into contact with the bridge 606 as discussed below.

The inserter 604 includes a flex bridge 654 which extends between the bodies 626, 628. The flex bridge 654 is curved or bent so that the flex bridge 654 is deformable, preferably elastically deformable. The flex bridge 654 maintains the bodies 626, 628 in a desired spatial configuration. The flex bridge 654 may be integrally formed with the inserter 604, or it may be a separate part that is attached between the bodies 626, 628.

The inserter 604 is shown in its free state, in which the inserter 604 is not elastically or plastically deflected or deformed. In one example of the free state, the inserter 604 experiences no external loads, other than gravity perhaps. However, in the free state, the inserter 604 may experience loads that are below a threshold for elastic or plastic deflection or deformation. In the free state, the proximal portions 632, 636 are separated by a gap 644 having a free state dimension 646. In the free state, the central junction 642 may contact the bridge 606, or the central junction 642 may optionally be separated from the bridge by a gap 648.

The inserter 604 may be moved between the free state and an actuated state by moving or pressing the proximal portions 632, 636 towards each other and towards the plane 625, thereby changing the shape of the inserter 604. This can be done manually, for example with an index finger on the left proximal portion 632 and a thumb on the right proximal portion 636. In other examples, the proximal portions 632, 636 may be moved away from each other or otherwise moved relative to each other, to move the inserter 604 between the free state and the actuated state. The actuated state may be referred to as a compressed state, an insertion state, or an implantation state. When the inserter 604 is moved from the free state to the actuated state, the gap 644 becomes smaller, the bodies 626, 628 pivot about the connections 638, 640 respectively, the flex bridge 654 deforms, and the central junction 642 presses against the bridge 606, thus causing the staple 602 to move from the free state to the elastically deformed state. Conversely, as the inserter 604 is moved from the actuated state to the free state, the staple 602 moves from the elastically deformed state to the free state.

When the inserter 604 is in the actuated state and the staple 602 is in the elastically deformed state, the delivery device 600 may be used to implant the staple 602. After the staple 602 has been implanted, the connections 638, 640 may be ruptured. The inserter 604 may then be removed from the implantation site, leaving the staple 602 in place.

Methods of manufacturing the delivery device 600 may include: (1) forming the staple 602 from a first material; forming the inserter 604 from a second material that may be the same as or different from the first material; and securing the staple 602 and the inserter 604 together; (3) forming the staple 602 from the first material; and forming the inserter 604 from the second material in contact with the previously formed staple 602; or (4) forming the inserter 604 from the second material; and forming the staple 602 from the first material in contact with the previously formed inserter 604. Shaping may involve molding, cutting, additive manufacturing processes, or the like. Molding may involve injection molding, insert molding, over molding, or the like. Cutting may involve laser cutting. Additive manufacturing may involve three-dimensional printing.

A method of using the delivery device 600 may include any or all of the following steps in any order: connecting the staple 602 to the inserter 604; making a first hole in a first body part; making a second hole in a second body part; moving the inserter 604 from the free state to the actuated state; moving the staple 602 from the free state to the elastically deformed state; moving the legs 612, 614 to be parallel; inserting the left leg 612 into the first hole; inserting the right leg 614 into the second hole; seating the bridge 606 against the first and/or second body part; moving the inserter 604 from the actuated state toward the free state; moving the staple 602 from the elastically deformed state toward the free state; moving the legs 612, 614 toward a converging state; rupturing the connections 638, 640; and removing the inserter 604 from the implantation site, leaving the staple 602 in place.

Making the first and/or second holes may involve drilling the first and/or second holes, optionally using a drill guide. The first hole may be substantially parallel to the second hole. The first and/or second body parts may be bone. Moving the inserter 604 from the free state to the actuated state may occur substantially in advance of a surgical procedure in which the delivery device 600 is used or immediately before inserting the legs 612, 614 into the first and second holes, respectively. Moving the inserter 604 from the free state to the actuated state may cause the staple 602 to move from the free state to the elastically deformed state. When the staple 602 is in the elastically deformed state, the left leg 612 may be substantially parallel to the right leg 614. Inserting the legs 612, 614 into the first and second holes, respectively, may involve partially or completely provisionally inserting the legs 612, 614 into the first and second holes and partially or completely withdrawing the legs 612, 614 from the first and second holes, while the inserter 604 is in the actuated state, and/or while the staple 602 is in the elastically deformed state, and/or before rupturing the connections 638, 640. Seating the bridge 606 against the first and/or second body part may involve direct contact between a bone facing side of the bridge 606 (a surface of the bridge 606 that faces towards the distal ends 618, 622) and a surface of the first and/or second body part. Moving the inserter 604 from the actuated state toward the free state may involve releasing pressure on the proximal portions 632, 636 acting to urge the proximal portions 632, 636 towards each other and towards the plane 625. Moving the inserter 604 from the actuated state toward the free state may cause the staple 602 to move from the elastically deformed state toward the free state. The inserter 604 and the staple 602 may relax toward their respective free states, but under certain circumstances they may not completely achieve their free states. Rupturing the connections may occur while the inserter 604 is in the actuated state and/or while the staple 602 is in the elastically deformed state. Rupturing the connections may cause the staple 602 to move from the elastically deformed state toward the free state.

Referring to FIG. 7 , yet another delivery device 700 includes a staple 702 and an inserter 704. In this example, the staple 702 and inserter 704 are integrally formed as a monolithic delivery device 700. The staple 702 and inserter 704 may be made of a polymer such as PEEK or a polymeric composition based upon PEEK. Alternatively, the staple 702 may be made of a first polymer and the inserter 704 may be made of a second polymer which is different from the first polymer. In this arrangement, the staple 702 and the inserter 704 may be coupled together to form the delivery device 700, for example by bonding, for example by melt bonding. The staple 702 and inserter 704 may also be made of metal, such as a nickel titanium alloy.

The staple 702 may be similar to the staple 302. The staple 702 includes a bridge 706 which extends longitudinally between a left end 708 and a right end 710. The staple 702 includes a left leg 712 and a right leg 714. A proximal end 716 of the left leg 712 is attached to the left end 708 of the bridge 706. The left leg 712 terminates in a distal end 718, which is a free end opposite the bridge 706. A proximal end 720 of the right leg 714 is attached to the right end 710 of the bridge 706. The right leg 714 terminates in a distal end 722, which is a free end opposite the bridge 706. The facing surfaces of the legs 712, 714 include teeth 724. When the staple 702 is implanted, the teeth 724 help to retain the staple 702 in the desired position. The teeth 724 may be on any or all sides of the legs 712, 714.

The staple 702 includes a reinforcing member 750 which may be metal, for example a nickel titanium alloy. The reinforcing member 750 may have a rectangular, square, or round cross section. The reinforcing member 750 may be easily fabricated from ribbon stock, square wire stock, or round wire stock. The reinforcing member 750 extends along the bridge 706 and optionally part way along the legs 712, 714. The reinforcing member 750 may extend along 50-90% of the length of each leg 712, 714. The reinforcing member 750 may be partially or wholly embedded in the bridge 706 and the legs 712, 714 of the staple 702, or it may be attached to the surface of the bridge 706 and the legs 712, 714. The staple 702 may include a base member 752, which in this example is the polymer portion of the staple 702 other than the reinforcing member 750. The base member 752 may be easily molded with the desired three-dimensional characteristics for the staple 702. The base member 752 may include a channel into which the reinforcing member 750 is fitted. The staple 702 may be referred to as a hybrid staple 702 because it includes a polymer base member 752 and a metal reinforcing member 750.

The staple 702 is shown in its free state, in which the staple 702 is not elastically or plastically deflected or deformed. The free state may be referred to as the closed state. In one example of the free state, the staple 702 experiences no external loads, other than gravity perhaps. However, in the free state, the staple 702 may experience loads that are below a threshold for elastic or plastic deflection or deformation. In the free state, the distal ends 718, 722 of the legs 712, 714 are closer together than the proximal ends 716, 720 so that the legs 712, 714 converge as they extend away from the bridge 706. The reinforcing member 750 is preferably in the form of a shallow upwards curve, convex on the proximal side and concave on the distal side facing the distal ends 718, 722. The reinforcing member 750 may maintain the legs 712, 714 in the free state.

The staple 702 may be moved between the free state and an elastically deformed state by elastically deforming some or all of the staple 702, including corresponding portions of the reinforcing member 750. For example, elastically deflecting or pressing on the bridge 706 so that it is straight or curves down between the legs 712, 714 causes the distal ends 718, 722 to spread apart. The legs 712, 714 may spread apart in the elastically deformed state so as to become parallel, as indicated by the dashed lines and movement arrows next to the legs 712, 714 in FIG. 7 . The elastically deformed state may be referred to as the open state. The elastically deformed state may be suitable for implantation of the staple 702 and may thus be referred to as an insertion state or an implantation state.

The inserter 704 may be referred to as a delivery member. The inserter 704 includes a left body 726 and a right body 728 which in this example is a mirror image of the left body 726 across a first plane of symmetry 725. The left body 726 includes a distal portion 730 and a proximal portion 732. The right body 728 includes a distal portion 734 and a proximal portion 736. The left distal portion 730 is connected to the left end 708 of the bridge 706 by a left connection 738. The right distal portion 734 is connected to the right end 710 of the bridge 706 by a right connection 740. The distal portions 730, 734 are connected to the bridge 706 solely by the connections 738, 740, which are at or close to the ends 708, 710. The connections 738, 740 may be ruptured after the staple 702 has been implanted, to disconnect the inserter 704 from the staple 702. For example, the connections 738, 740 may be ruptured by use of a surgical wire cutter, scissors, a scalpel, or a rupturing instrument specifically designed to correspond to the connections 738, 740, or by being manually broken. After rupture, the bridge 706 may include residue from the ruptured connections 738, 740. The integral connections 738, 740 shown may be replaced by the connections 538, 540 or the securing members 656, 658, locking members 660, 662, and recesses 664, 672 shown in FIG. 6 for delivery device 600. The distal portions 730, 734 extend along and above the bridge 706 and are joined together at a central junction 742 which is shown in the vicinity of the plane 725. The distal portion 730 is joined to the central junction 742 by a left flexible joint 741 and the distal portion 734 is joined to the central junction 742 by a right flexible joint 743. The central junction 742 is not secured to the bridge 706, but can be brought into contact with the bridge 706 as discussed below. A central component 744 extends proximally from the central junction 742 and becomes bilaterally enlarged in a left to right direction as it extends proximally. The proximal side of the central component 744 is flat so that pressure or force may be applied to it manually or with an instrument.

The inserter 704 is shown in its free state, in which the inserter 704 is not elastically or plastically deflected or deformed. In one example of the free state, the inserter 704 experiences no external loads, other than gravity perhaps. However, in the free state, the inserter 704 may experience loads that are below a threshold for elastic or plastic deflection or deformation. In the free state, the central junction 742 may contact the bridge 706, or the central junction 742 may optionally be separated from the bridge by a gap 748.

The inserter 704 may be moved between the free state and an actuated state by moving or pressing the proximal portions 732, 736 towards each other and towards the plane 725 and by moving or pressing the central component 744 distally, thereby changing the shape of the inserter 704. This can be done manually, for example with an index finger on the distal aspect of the left proximal portion 732, a middle finger on the distal aspect of the right proximal portion 736, and a thumb on the proximal aspect of the central component 744. In other examples, the proximal portions 732, 736 may be moved away from each other or otherwise moved relative to each other, to move the inserter 704 between the free state and the actuated state. The actuated state may be referred to as a compressed state, an insertion state, or an implantation state. When the inserter 704 is moved from the free state to the actuated state, the bodies 726, 728 pivot towards each other and towards the first plane of symmetry about the connections 738, 740 respectively, and the central junction 742 presses against the bridge 706, thus causing the staple 702 to move from the free state to the elastically deformed state. Conversely, as the inserter 704 is moved from the actuated state to the free state, the staple 702 moves from the elastically deformed state to the free state. The reinforcing member 750 may urge the base member 752 toward the free state and may increase the post-implantation compressive force of the staple 702 compared to unreinforced polymer staples.

When the inserter 704 is in the actuated state and the staple 702 is in the elastically deformed state, the delivery device 700 may be used to implant the staple 702. After the staple 702 has been implanted, the connections 738, 740 may be ruptured. The inserter 704 may then be removed from the implantation site, leaving the staple 702 in place.

Methods of manufacturing the delivery device 700 may include: (1) forming the base member 752 and the inserter 704 as a monolithic article by shaping a single material in a single step; forming the reinforcing member 750 from metal, preferably a nickel titanium alloy; and connecting the reinforcing member 750 to the base member 752; (2) forming the base member 752 from a first material; forming the inserter 704 from a second material that may be the same as or different from the first material; forming the reinforcing member 750 from a third material that is metal, preferably a nickel titanium alloy; and securing the base member 752, the inserter 704, and the reinforcing member 750 together; (3) forming the reinforcing member 750 from the third material; forming the base member 752 from the first material in contact with the previously formed reinforcing member 750 to form the staple 702; and forming the inserter 704 from the second material in contact with the previously formed staple 702; or (4) forming the inserter 704 from the second material; forming the reinforcing member 750 from the third material; and forming the base member 752 from the first material in contact with the previously formed inserter 704 and reinforcing member 750. The steps of forming the base member 352 and the inserter 704 as a monolithic article and connecting the reinforcing member 750 may occur simultaneously, for example as an overmolding or insert molding operation. Shaping may involve molding, cutting, additive manufacturing processes, or the like. Molding may involve injection molding, insert molding, over molding, or the like. Cutting may involve laser cutting. Additive manufacturing may involve three-dimensional printing.

A method of using the delivery device 700 may include any or all of the following steps in any order: making a first hole in a first body part; making a second hole in a second body part; moving the inserter 704 from the free state to the actuated state; moving the staple 702 from the free state to the elastically deformed state; moving the legs 712, 714 to be parallel; inserting the left leg 712 into the first hole; inserting the right leg 714 into the second hole; seating the bridge 706 against the first and/or second body part; moving the inserter 704 from the actuated state toward the free state; moving the staple 702 from the elastically deformed state toward the free state; moving the legs 712, 714 toward a converging state; rupturing the connections 738, 740; and removing the inserter 704 from the implantation site, leaving the staple 702 in place.

Making the first and/or second holes may involve drilling the first and/or second holes, optionally using a drill guide. The first hole may be substantially parallel to the second hole. The first and/or second body parts may be bone. Moving the inserter 704 from the free state to the actuated state may occur substantially in advance of a surgical procedure in which the delivery device 700 is used or immediately before inserting the legs 712, 714 into the first and second holes, respectively. Moving the inserter 704 from the free state to the actuated state may cause the staple 702 to move from the free state to the elastically deformed state. When the staple 702 is in the elastically deformed state, the left leg 712 may be substantially parallel to the right leg 714. Inserting the legs 712, 714 into the first and second holes, respectively, may involve partially or completely provisionally inserting the legs 712, 714 into the first and second holes and partially or completely withdrawing the legs 712, 714 from the first and second holes, while the inserter 704 is in the actuated state, and/or while the staple 702 is in the elastically deformed state, and/or before rupturing the connections 738, 740. Seating the bridge 706 against the first and/or second body part may involve direct contact between a bone facing side of the bridge 706 (a surface of the bridge 706 that faces towards the distal ends 718, 722) and a surface of the first and/or second body part. Moving the inserter 704 from the actuated state toward the free state may involve releasing pressure on the proximal portions 732, 736 acting to urge the proximal portions 732, 736 towards each other and towards the plane 725. Moving the inserter 704 from the actuated state toward the free state may cause the staple 702 to move from the elastically deformed state toward the free state. The inserter 704 and the staple 702 may relax toward their respective free states, but under certain circumstances they may not completely achieve their free states. Rupturing the connections may occur while the inserter 704 is in the actuated state and/or while the staple 702 is in the elastically deformed state. Rupturing the connections may cause the staple 702 to move from the elastically deformed state toward the free state.

Referring to FIG. 8 , yet another delivery device 800 includes a staple 802 and an inserter 804. In this example, the inserter 804 and at least part of the staple 802 are integrally formed. The staple 802 and inserter 804 may be made of a polymer such as PEEK or a polymeric composition based upon PEEK. Alternatively, the staple 802 may be made of a first polymer and the inserter 804 may be made of a second polymer which is different from the first polymer. In this arrangement, the staple 802 and the inserter 804 may be coupled together to form the delivery device 800, for example by bonding, for example by melt bonding. The staple 802 and inserter 804 may also be made of metal.

The staple 802 includes a bridge 806 which extends longitudinally between a left end 808 and a right end 810. The staple 802 includes a left leg 812 and a right leg 814. A proximal end 816 of the left leg 812 is attached to the left end 808 of the bridge 806. The left leg 812 terminates in a distal end 818, which is a free end opposite the bridge 806. A proximal end 820 of the right leg 814 is attached to the right end 810 of the bridge 806. The right leg 814 terminates in a distal end 822, which is a free end opposite the bridge 806. The facing surfaces of the legs 812, 814 include teeth 824. When the staple 802 is implanted, the teeth 824 help to retain the staple 802 in the desired position. The teeth 824 may be on any or all sides of the legs 812, 814.

The staple 802 in this example is a three piece assembly of a metal bridge 806 and polymer legs 812, 814. The bridge 806 may be a nickel titanium alloy and the legs 812, 814 may be PEEK or a polymer composition based on PEEK. In other examples, the bridge 806 may be a first material, metal or polymer, and the legs 812, 814 may be a second material, metal or polymer, which is the same as or different from the first material. The metal bridge 806 may function similar to the reinforcing members described herein. The proximal ends 816, 820 of the legs 812, 814 are bilaterally enlarged at least in a left to right direction, and optionally in a front to back direction, relative to their respective distal ends 818, 822. The proximal end 816 includes a socket 850 which receives the left end 808 of the bridge 806 and the proximal end 820 includes a socket 852 which receives the right end 810. The staple 802 may be referred to as a hybrid staple 802 because it includes polymer legs 812, 814 and a metal bridge 806. The three piece assembly of a metal bridge and polymer legs may be incorporated in any of the staples 102, 302, 502, 602, 702, 900, 1100, 1800, 1400, 1500, 1600 disclosed herein.

The staple 802 is shown in its free state, in which the staple 802 is not elastically or plastically deflected or deformed. The free state may be referred to as the closed state. In one example of the free state, the staple 802 experiences no external loads, other than gravity perhaps. However, in the free state, the staple 802 may experience loads that are below a threshold for elastic or plastic deflection or deformation. In the free state, the distal ends 818, 822 of the legs 812, 814 are closer together than the proximal ends 816, 820 so that the legs 812, 814 converge as they extend away from the bridge 806. The bridge 806 is preferably in the form of a very shallow upwards curve, convex on the proximal side and concave on the distal side facing the distal ends 818, 822. The bridge 806 may maintain the legs 812, 814 in the free state.

The staple 802 may be moved between the free state and an elastically deformed state by elastically deforming some or all of the staple 802, including portions of the bridge 806. For example, elastically deflecting or pressing on the bridge 806 so that it is straight or curves down between the legs 812, 814 causes the distal ends 818, 822 to spread apart. The legs 812, 814 may spread apart in the elastically deformed state so as to become parallel. The elastically deformed state may be referred to as the open state. The elastically deformed state may be suitable for implantation of the staple 802 and may thus be referred to as an insertion state or an implantation state.

The inserter 804 may be similar to the inserter 704. The inserter 804 may be referred to as a delivery member. The inserter 804 includes a left body 826 and a right body 828 which in this example is a mirror image of the left body 826 across a first plane of symmetry 825, which is shown edge on in FIG. 8 and is therefore represented by a line 825. The left body 826 includes a distal portion 830 and a proximal portion 832. The right body 828 includes a distal portion 834 and a proximal portion 836. The left distal portion 830 is connected to the proximal end 816 of the left leg 812 by a left connection 838. The right distal portion 834 is connected to the proximal end 820 of the right leg 814 by a right connection 840. The distal portions 830, 834 are connected to the legs 812, 814, and thus to the bridge 806, solely by the connections 838, 840, which are at or close to the ends 808, 810. The connections 838, 840 may be ruptured after the staple 802 has been implanted, to disconnect the inserter 804 from the staple 802. For example, the connections 838, 840 may be ruptured by use of a surgical wire cutter, scissors, a scalpel, or a rupturing instrument specifically designed to correspond to the connections 838, 840, or by being manually broken. After rupture, the proximal ends 816, 820 may include residue from the ruptured connections 838, 840. The connections 838, 840 shown may be replaced by the connections 538, 540 or the securing members 656, 658, locking members 660, 662, and recesses 664, 672 shown in FIG. 6 for delivery device 600. The distal portions 830, 834 extend along and above the bridge 806 and are joined together at a central junction 842 which is shown in the vicinity of the plane 825. The distal portion 830 is joined to the central junction 842 by a left flexible joint 841 and the distal portion 834 is joined to the central junction 842 by a right flexible joint 843. The central junction 842 is not secured to the bridge 806, but can be brought into contact with the bridge 806 as discussed below. A central component 844 extends proximally from the central junction 842 and becomes bilaterally enlarged in a left to right direction as it extends proximally. The proximal side of the central component 844 is flat so that pressure or force may be applied to it manually or with an instrument.

The inserter 804 is shown in its free state, in which the inserter 804 is not elastically or plastically deflected or deformed. In one example of the free state, the inserter 804 experiences no external loads, other than gravity perhaps. However, in the free state, the inserter 804 may experience loads that are below a threshold for elastic or plastic deflection or deformation. In the free state, the central junction 842 may contact the bridge 806, or the central junction 842 may optionally be separated from the bridge by a gap 848.

The inserter 804 may be moved between the free state and an actuated state by moving or pressing the proximal portions 832, 836 towards each other and towards the plane 825 and by moving or pressing the central component 844 distally, thereby changing the shape of the inserter 804. This can be done manually, for example with an index finger on the distal aspect of the left proximal portion 832, a middle finger on the distal aspect of the right proximal portion 836, and a thumb on the proximal aspect of the central component 844. In other examples, the proximal portions 832, 836 may be moved away from each other or otherwise moved relative to each other, to move the inserter 804 between the free state and the actuated state. The actuated state may be referred to as a compressed state, an insertion state, or an implantation state. When the inserter 804 is moved from the free state to the actuated state, the bodies 826, 828 pivot towards each other and towards the first plane of symmetry about the connections 838, 840 respectively, and the central junction 842 presses against the bridge 806, thus causing the staple 802 to move from the free state to the elastically deformed state. Conversely, as the inserter 804 is moved from the actuated state to the free state, the staple 802 moves from the elastically deformed state to the free state. The metal bridge 806 may urge the staple 802 toward the free state and may increase the post-implantation compressive force of the staple 802 compared to an all-polymer staple.

When the inserter 804 is in the actuated state and the staple 802 is in the elastically deformed state, the delivery device 800 may be used to implant the staple 802. After the staple 802 has been implanted, the connections 838, 840 may be ruptured. The inserter 804 may then be removed from the implantation site, leaving the staple 802 in place.

The inserter 804 may be replaced by one of the inserters 104, 504, or 604.

Methods of manufacturing the delivery device 800 may include: (1) forming the legs 812, 814 and the inserter 804 as a monolithic article by shaping a single material in a single step; forming the bridge 806 of metal, preferably a nickel titanium alloy; and connecting the bridge 806 to the legs 812, 814; (2) forming the legs 812, 814 from a first material; forming the inserter 804 from a second material that may be the same as or different from the first material; forming the legs 812, 814 from a third material that is metal, preferably a nickel titanium alloy; and securing the legs 812, 814, the inserter 804, and the bridge 806 together; (3) forming the bridge 806 from the third material; forming the legs 812, 814 from the first material in contact with the previously formed bridge 806 to form the staple 802; and forming the inserter 804 from the second material in contact with the previously formed staple 802; or (4) forming the inserter 804 from the second material; forming the bridge 806 from the third material; and forming the legs 812, 814 from the first material in contact with the previously formed inserter 804 and bridge 806. The steps of forming the legs 812, 814 and the inserter 804 as a monolithic article and connecting the bridge 806 may occur simultaneously, for example as an overmolding or insert molding operation. Shaping may involve molding, cutting, additive manufacturing processes, or the like. Molding may involve injection molding, insert molding, over molding, or the like. Cutting may involve laser cutting. Additive manufacturing may involve three-dimensional printing.

A method of using the delivery device 800 may include any or all of the following steps in any order: making a first hole in a first body part; making a second hole in a second body part; moving the inserter 804 from the free state to the actuated state; moving the staple 802 from the free state to the elastically deformed state; moving the legs 812, 814 to be parallel; inserting the left leg 812 into the first hole; inserting the right leg 814 into the second hole; seating the bridge 806 against the first and/or second body part; moving the inserter 804 from the actuated state toward the free state; moving the staple 802 from the elastically deformed state toward the free state; moving the legs 812, 814 toward a converging state; rupturing the connections 838, 840; and removing the inserter 804 from the implantation site, leaving the staple 802 in place.

Making the first and/or second holes may involve drilling the first and/or second holes, optionally using a drill guide. The first hole may be substantially parallel to the second hole. The first and/or second body parts may be bone. Moving the inserter 804 from the free state to the actuated state may occur substantially in advance of a surgical procedure in which the delivery device 800 is used or immediately before inserting the legs 812, 814 into the first and second holes, respectively. Moving the inserter 804 from the free state to the actuated state may cause the staple 802 to move from the free state to the elastically deformed state. When the staple 802 is in the elastically deformed state, the left leg 812 may be substantially parallel to the right leg 814. Inserting the legs 812, 814 into the first and second holes, respectively, may involve partially or completely provisionally inserting the legs 812, 814 into the first and second holes and partially or completely withdrawing the legs 812, 814 from the first and second holes, while the inserter 804 is in the actuated state, and/or while the staple 802 is in the elastically deformed state, and/or before rupturing the connections 838, 840. Seating the bridge 806 against the first and/or second body part may involve direct contact between a bone facing side of the bridge 806 (a surface of the bridge 806 that faces towards the distal ends 818, 822) and a surface of the first and/or second body part. Moving the inserter 804 from the actuated state toward the free state may involve releasing pressure on the proximal portions 832, 836 acting to urge the proximal portions 832, 836 towards each other and towards the plane 825. Moving the inserter 804 from the actuated state toward the free state may cause the staple 802 to move from the elastically deformed state toward the free state. The inserter 804 and the staple 802 may relax toward their respective free states, but under certain circumstances they may not completely achieve their free states. Rupturing the connections may occur while the inserter 804 is in the actuated state and/or while the staple 802 is in the elastically deformed state. Rupturing the connections may cause the staple 802 to move from the elastically deformed state toward the free state.

Referring to FIGS. 9 and 10 , a staple 900 may be similar to, or identical to, staple 602 of delivery device 600. The staple 900 may be made of a metal, such as a nickel-titanium alloy, or a polymer such as PEEK or a polymeric composition based on PEEK. The staple 900, whether metal or polymer, may connect to inserter 604 in the same way as staple 602.

The staple 900 includes a bridge 906 which extends longitudinally between a left end 908 and a right end 910. The staple 900 includes a left leg 912 and a right leg 914. A proximal end 916 of the left leg 912 is attached to the left end 908 of the bridge 906. The left leg 912 terminates in a distal end 918, which is a free end opposite the bridge 906. A proximal end 920 of the right leg 914 is attached to the right end 910 of the bridge 906. The right leg 914 terminates in a distal end 922, which is a free end opposite the bridge 906. The facing surfaces of the legs 912, 914 include teeth 924. When the staple 900 is implanted, the teeth 924 help to retain the staple 900 in the desired position. The teeth 924 may be on any or all sides of the legs 912, 914.

The staple 900 includes left and right securing members 956, 958 which function as left and right connections 938, 940 very similar to the connections 538, 540. The left securing member 956 extends from the left end 908 of the bridge 906 opposite the left leg 912, and terminates in a left locking member 960. The right securing member 958 extends from the right end 910 of the bridge 906 opposite the right leg 914, and terminates in a right locking member 962. Each locking member 960, 962 is bilaterally enlarged in the left-right direction relative to its respective securing member 956, 958, so that bilateral undercuts are formed at the transition between the locking member and the securing member. The locking members 960, 962 are shaped like arrowheads in this example. There are notches 950 on both sides of the left securing member 956 at the connection with the left end 908 of the bridge 906. There are notches 952 on both sides of the right securing member 958 at the connection with the right end 910 of the bridge 906.

The staple 900 is shown in its free state, in which the staple 900 is not elastically or plastically deflected or deformed. The free state may be referred to as the closed state. In one example of the free state, the staple 900 experiences no external loads, other than gravity perhaps. However, in the free state, the staple 900 may experience loads that are below a threshold for elastic or plastic deflection or deformation. In the free state, the distal ends 918, 922 of the legs 912, 914 are closer together than the proximal ends 916, 920 so that the legs 912, 914 converge as they extend away from the bridge 906.

The staple 900 may be moved between the free state and an elastically deformed state by elastically deforming some or all of the staple 900. For example, elastically deflecting or pressing on the bridge 906 so that it is straight or curves down between the legs 912, 914 causes the distal ends 918, 922 to spread apart. The legs 912, 914 may spread apart in the elastically deformed state so as to become parallel. The elastically deformed state may be referred to as the open state. The elastically deformed state may be suitable for implantation of the staple 900 and may thus be referred to as an insertion state or an implantation state.

Referring to FIGS. 11 and 12 , another staple 1100 may be similar to, or substantially identical to, staple 602 of delivery device 500. Staple 1100 may connect to inserter 604 in the same way as staple 602. Staple 1100 may be made of a polymer such as PEEK or a polymeric composition based on PEEK.

The staple 1100 includes a bridge 1106 which extends longitudinally between a left end 1108 and a right end 1110. The staple 1100 includes a left leg 1112 and a right leg 1114. A proximal end 1116 of the left leg 1112 is attached to the left end 1108 of the bridge 1106. The left leg 1112 terminates in a distal end 1118, which is a free end opposite the bridge 1106. A proximal end 1120 of the right leg 1114 is attached to the right end 1110 of the bridge 1106. The right leg 1114 terminates in a distal end 1122, which is a free end opposite the bridge 1106. The facing surfaces of the legs 1112, 1114 include teeth 1124. When the staple 1100 is implanted, the teeth 1124 help to retain the staple 1100 in the desired position. The teeth 1124 may be on any or all sides of the legs 1112, 1114.

The staple 1100 includes a reinforcing member 1146 which may be metal, for example a nickel titanium alloy. The reinforcing member 1146 may have a rectangular, square, or round cross section. The reinforcing member 1146 may be easily fabricated from ribbon stock, square wire stock, or round wire stock. The example shown has a rectangular cross section and is made from ribbon stock. The reinforcing member 1146 extends along the bridge 1106 and optionally part way along the legs 1112, 1114. The reinforcing member 1146 may extend along 50-90% of the length of each leg 1112, 1114. The reinforcing member 1146 may be partially or wholly embedded in the bridge 1106 and the legs 1112, 1114 of the staple 1100, or it may be attached to the surface of the bridge 1106 and the legs 1112, 1114. The staple 1100 may include a base member 1148, which in this example is the polymer portion of the staple 1100 other than the reinforcing member 1146. The base member 1148 may be easily molded with the desired three-dimensional characteristics for the staple 1100. The base member 1148 is shown with a channel 1154 that receives the reinforcing member 1146. The staple 1100 may be referred to as a hybrid staple 1100 because it includes a polymer base member 1148 and a metal reinforcing member 1146.

The staple 1100 includes left and right securing members 1156, 1158 which function as left and right connections 1138, 1140 very similar to the connections 538, 540. In this example, the securing members 1156, 1158 are integrally formed with the base member 1148, although they could be carried by the reinforcing member in other examples. The left securing member 1156 extends from the left end 1108 of the bridge 1106 opposite the left leg 1112, and terminates in a left locking member 1160. The right securing member 1158 extends from the right end 1110 of the bridge 1106 opposite the right leg 1114, and terminates in a right locking member 1162. Each locking member 1160, 1162 is bilaterally enlarged in the left-right direction relative to its respective securing member 1156, 1158, so that bilateral undercuts are formed at the transition between the locking member and the securing member. The locking members 1160, 1162 are shaped like arrowheads in this example. There are notches 1150 on both sides of the left securing member 1156 at the connection with the left end 1108 of the bridge 1106. There are notches 1152 on both sides of the right securing member 1158 at the connection with the right end 1110 of the bridge 1106.

The staple 1100 is shown in its free state, in which the staple 1100 is not elastically or plastically deflected or deformed. The free state may be referred to as the closed state. In one example of the free state, the staple 1100 experiences no external loads, other than gravity perhaps. However, in the free state, the staple 1100 may experience loads that are below a threshold for elastic or plastic deflection or deformation. In the free state, the distal ends 1118, 1122 of the legs 1112, 1114 are closer together than the proximal ends 1116, 1120 so that the legs 1112, 1114 converge as they extend away from the bridge 1106. The reinforcing member 1146 may maintain the legs 1112, 1114 in the free state.

The staple 1100 may be moved between the free state and an elastically deformed state by elastically deforming some or all of the staple 1100. For example, elastically deflecting or pressing on the bridge 1106 so that it is straight or curves down between the legs 1112, 1114 causes the distal ends 1118, 1122 to spread apart. The legs 1112, 1114 may spread apart in the elastically deformed state so as to become parallel. The elastically deformed state may be referred to as the open state. The elastically deformed state may be suitable for implantation of the staple 1100 and may thus be referred to as an insertion state or an implantation state. The reinforcing member 1146 may urge the base member 1148 from the elastically deformed state toward the free state and may increase the post-implantation compressive force of the staple 1100 compared to unreinforced polymer staples.

Referring to FIGS. 13A-13C, yet another staple 1300 includes a bridge 1306 which extends longitudinally between a left end 1308 and a right end 1310. The staple 1300 includes a left leg 1312 and a right leg 1314. A proximal end 1316 of the left leg 1312 is attached to the left end 1308 of the bridge 1306. The left leg 1312 terminates in a distal end 1318, which is a free end opposite the bridge 1306. A proximal end 1320 of the right leg 1314 is attached to the right end 1310 of the bridge 1306. The right leg 1314 terminates in a distal end 1322, which is a free end opposite the bridge 1306. The facing surfaces of the legs 1312, 1314 include teeth 1324. When the staple 1300 is implanted, the teeth 1324 help to retain the staple 1300 in the desired position. The teeth 1324 may be on any or all sides of the legs 1312, 1314.

The staple 1300 includes a reinforcing member 1350 which may be metal, for example a nickel titanium alloy. The reinforcing member 1350 in this example has a C-shaped cross section and thus forms a channel that is open on its distal side facing the distal ends 1318, 1322. The reinforcing member 1350 extends along the bridge 1306. The reinforcing member 1350 may be partially or wholly embedded in the bridge 1306 and the legs 1312, 1314 of the staple 1300, or it may be attached to the surface of the bridge 1306 and the legs 1312, 1314. In the example, the reinforcing member 1350 is attached to the front, proximal, and back surfaces of the bridge 1306 by a dovetail connection, although other undercut sliding connections are contemplated. The staple 1300 may include a base member 1352, which in this example is the polymer portion of the staple 1300 other than the reinforcing member 1350. The base member 1352 may be made of PEEK or a polymeric composition based on PEEK. The base member 1352 may be easily molded with the desired three-dimensional characteristics for the staple 1300. Referring to FIG. 13C, the base member 1352 includes a dovetail rail 1354 and the reinforcing member 1350 includes a complementary close-fitting dovetail channel. The staple 1300 may be referred to as a hybrid staple 1300 because it includes a polymer base member 1352 and a metal reinforcing member 1350.

The staple 1300 is shown in its free state, in which the staple 1300 is not elastically or plastically deflected or deformed. The free state may be referred to as the closed state. In one example of the free state, the staple 1300 experiences no external loads, other than gravity perhaps. However, in the free state, the staple 1300 may experience loads that are below a threshold for elastic or plastic deflection or deformation. In the free state, the distal ends 1318, 1322 of the legs 1312, 1314 are closer together than the proximal ends 1316, 1320 so that the legs 1312, 1314 converge as they extend away from the bridge 1306. The reinforcing member 1350 may maintain the legs 1312, 1314 in the free state.

The staple 1300 may be moved between the free state and an elastically deformed state by elastically deforming some or all of the staple 1300, including corresponding portions of the reinforcing member 1350. For example, elastically deflecting or pressing on the bridge 1306 so that it is straight or curves down between the legs 1312, 1314 causes the distal ends 1318, 1322 to spread apart. The legs 1312, 1314 may spread apart in the elastically deformed state so as to become parallel. The elastically deformed state may be referred to as the open state. The elastically deformed state may be suitable for implantation of the staple 1300 and may thus be referred to as an insertion state or an implantation state. The reinforcing member 1350 may urge the base member 1352 from the elastically deformed state toward the free state and may increase the post-implantation compressive force of the staple 1300 compared to unreinforced polymer staples.

Referring to FIGS. 14A-14C, yet another staple 1400 may be similar to staple 1300. Staple 1400 includes a bridge 1406 which extends longitudinally between a left end 1408 and a right end 1410. The staple 1400 includes a left leg 1412 and a right leg 1414. A proximal end 1416 of the left leg 1412 is attached to the left end 1408 of the bridge 1406. The left leg 1412 terminates in a distal end 1418, which is a free end opposite the bridge 1406. A proximal end 1420 of the right leg 1414 is attached to the right end 1410 of the bridge 1406. The right leg 1414 terminates in a distal end 1422, which is a free end opposite the bridge 1406. The facing surfaces of the legs 1412, 1414 include teeth 1424. When the staple 1400 is implanted, the teeth 1424 help to retain the staple 1400 in the desired position. The teeth 1424 may be on any or all sides of the legs 1412, 1414.

The staple 1400 includes a reinforcing member 1450 which may be metal, for example a nickel titanium alloy. The reinforcing member 1450 in this example has a C-shaped cross section and thus forms a channel that is open on its distal side facing the distal ends 1418, 1422. The reinforcing member 1450 extends along the bridge 1406. The reinforcing member 1450 may be partially or wholly embedded in the bridge 1406 and the legs 1412, 1414 of the staple 1400, or it may be attached to the surface of the bridge 1406 and the legs 1412, 1414. In the example, the reinforcing member 1450 is attached to the front, proximal, and back surfaces of the bridge 1406 by a dovetail connection, although other undercut sliding connections are contemplated. The staple 1400 may include a base member 1452, which in this example is the polymer portion of the staple 1400 other than the reinforcing member 1450. The base member 1452 may be made of PEEK or a polymeric composition based on PEEK. The base member 1452 may be easily molded with the desired three-dimensional characteristics for the staple 1400. Referring to FIG. 14C, the base member 1452 includes a dovetail rail 1454 and the reinforcing member 1450 includes a complementary close-fitting dovetail channel 1456. The staple 1400 may be referred to as a hybrid staple 1400 because it includes a polymer base member 1452 and a metal reinforcing member 1450.

The staple 1400 is shown in its free state, in which the staple 1400 is not elastically or plastically deflected or deformed. The free state may be referred to as the closed state. In one example of the free state, the staple 1400 experiences no external loads, other than gravity perhaps. However, in the free state, the staple 1400 may experience loads that are below a threshold for elastic or plastic deflection or deformation. In the free state, the distal ends 1418, 1422 of the legs 1412, 1414 are closer together than the proximal ends 1416, 1420 so that the legs 1412, 1414 converge as they extend away from the bridge 1406. The reinforcing member 1450 may maintain the legs 1412, 1414 in the free state.

The staple 1400 may be moved between the free state and an elastically deformed state by elastically deforming some or all of the staple 1400, including corresponding portions of the reinforcing member 1450. For example, elastically deflecting or pressing on the bridge 1406 so that it is straight or curves down between the legs 1412, 1414 causes the distal ends 1418, 1422 to spread apart. The legs 1412, 1414 may spread apart in the elastically deformed state so as to become parallel. The elastically deformed state may be referred to as the open state. The elastically deformed state may be suitable for implantation of the staple 1400 and may thus be referred to as an insertion state or an implantation state. The reinforcing member 1450 may urge the base member 1452 from the elastically deformed state toward the free state and may increase the post-implantation compressive force of the staple 1400 compared to unreinforced polymer staples.

Referring to FIG. 15 , yet another staple 1500 includes a bridge 1506 which extends longitudinally between a left end 1508 and a right end. In this example, the right hand portion of the bridge bifurcates into a right front bridge 1506′ which extends to a front right end 1510′, and a right back bridge 1506″ which extends to a back right end 1510″. The staple 1500 includes a left leg 1512, a front right leg 1514′, and a back right leg 1514″. A proximal end 1516 of the leg 1512 is attached to the left end 1508 of the bridge 1506. The leg 1512 terminates in a distal end 1518, which is a free end opposite the bridge 1506. A proximal end 1520′ of the leg 1514′ is attached to the front right end 1510′ of the bridge 1506′. The leg 1514′ terminates in a distal end 1522′, which is a free end opposite the bridge 1506′. A proximal end 1520″ of the leg 1514″ is attached to the back right end 1510″ of the bridge 1506″. The leg 1514″ terminates in a distal end 1522″, which is a free end opposite the bridge 1506″. The facing surfaces of the legs 1512, 1514′, 1514″ include teeth 1524. When the staple 1500 is implanted, the teeth 1524 help to retain the staple 1500 in the desired position. The teeth 1524 may be on any or all sides of the legs 1512, 1514.

The staple 1500 includes a front reinforcing member 1550′ and a back reinforcing member 1550″. The reinforcing members 1550′, 1550″ may be metal, for example a nickel titanium alloy. The reinforcing members 1550′, 1550″ may have a rectangular, square, or round cross section. The reinforcing members 1550′, 1550″ may be easily fabricated from ribbon stock, square wire stock, or round wire stock. The reinforcing member 1550′ extends along the bridge 1506, 1506′ and optionally part way along the legs 1512, 1514′. The reinforcing member 1550′ may extend along 50-90% of the length of each leg 1512, 1514′. The reinforcing member 1550″ extends along the bridge 1506, 1506″ and optionally part way along the legs 1512, 1514″. The reinforcing member 1550″ may extend along 50-90% of the length of each leg 1512, 1514″. The reinforcing members 1550′, 1550″ may be partially or wholly embedded in the bridge 1506, 1506′, 1506″ and the legs 1512, 1514′, 1514″ of the staple 1500, or they may be attached to the surface of the bridge 1506, 1506′, 1506″ and the legs 1512, 1514′, 1514″. The staple 1500 may include a base member 1552, which in this example is the polymer portion of the staple 1500 other than the reinforcing members 1550′, 1550″. The base member 1552 may be easily molded with the desired three-dimensional characteristics for the staple 1500. In this example, the base member 1552 includes channels 1554′, 1554″ that receive the reinforcing members 1550′, 1550″ respectively. The channels 1554′, 1554″ merge into a common channel 1554 towards the left end 1508 of the bridge 1506. The staple 1500 may be referred to as a hybrid staple 1500 because it includes a polymer base member 1552 and metal reinforcing members 1550′, 1550″.

The staple 1500 is shown in its free state, in which the staple 1500 is not elastically or plastically deflected or deformed. The free state may be referred to as the closed state. In one example of the free state, the staple 1500 experiences no external loads, other than gravity perhaps. However, in the free state, the staple 1500 may experience loads that are below a threshold for elastic or plastic deflection or deformation. In the free state, the distal ends 1518, 1522′, 1522″ of the legs 1512, 1514′, 1514″ are closer together than the proximal ends 1516, 1520′, 1520″ so that the legs 1512, 1514′, 1514″ converge as they extend away from the bridge 1506, 1506′, 1506″. The reinforcing members 1550′, 1550″ may maintain the legs 1512, 1514′, 1514″ in the free state.

The staple 1500 may be moved between the free state and an elastically deformed state by elastically deforming some or all of the staple 1500, including corresponding portions of the reinforcing members 1550′, 1550″. For example, elastically deflecting or pressing on one or more of the three bridge portions 1506, 1506′, 1506″ so that it is straight or curves down between the legs 1512, 1514′, 1514″ causes one or more of the distal ends 1518, 1522′, 1522″ to spread apart. Alternatively, one or more of the legs 1512, 1514′, 1514″ may be elastically deflected so that one or more of the distal ends 1518, 1522′, 1522″ spread apart or come closer together. The legs 1512, 1514′, 1514″ may spread apart in the elastically deformed state so as to become parallel. The elastically deformed state may be referred to as the open state. The elastically deformed state may be suitable for implantation of the staple 1500 and may thus be referred to as an insertion state or an implantation state. The reinforcing members 1550′, 1550″ may urge the base member 1552 from the elastically deformed state toward the free state and may increase the post-implantation compressive force of the staple 1500 compared to unreinforced polymer staples.

Referring to FIG. 16 , yet another staple 1600 includes a front bridge 1606 which extends longitudinally between a left end 1608 and a right end 1610, and a back bridge 1656 which extends longitudinally between a left end 1658 and a right end 1660. The bridges 1606, 1656 are connected together and held spaced apart front to back by left and right arms 1626, 1628. An aperture 1630 extends between the arms 1626, 1628. The staple 1600 includes a front left leg 1612, a front right leg 1614, a back left leg 1662, and a back right leg 1664. A proximal end 1616 of the leg 1612 is attached to the front left end 1608 of the bridge 1606. The leg 1612 terminates in a distal end 1618, which is a free end opposite the bridge 1606. A proximal end 1620 of the leg 1614 is attached to the front right end 1610 of the bridge 1606. The leg 1614 terminates in a distal end 1622, which is a free end opposite the bridge 1606. A proximal end 1666 of the leg 1662 is attached to the back left end 1658 of the bridge 1656. The leg 1662 terminates in a distal end 1668, which is a free end opposite the bridge 1656. A proximal end 1670 of the leg 1664 is attached to the back right end 1660 of the bridge 1656. The leg 1664 terminates in a distal end 1672, which is a free end opposite the bridge 1656.

The facing surfaces of the legs 1612, 1614, 1662, 1664 include teeth 1624. When the staple 1600 is implanted, the teeth 1624 help to retain the staple 1600 in the desired position. The teeth 1624 may be on any or all sides of the legs 1612, 1614, 1662, 1664.

The staple 1600 includes a front reinforcing member 1650 and a back reinforcing member 1674. The reinforcing members 1650, 1674 may be metal, for example a nickel titanium alloy. The reinforcing members 1650, 1674 may have a rectangular, square, or round cross section. The reinforcing members 1650, 1674 may be easily fabricated from ribbon stock, square wire stock, or round wire stock. The reinforcing member 1650 extends along the bridge 1606 and optionally part way along the legs 1612, 1614. The reinforcing member 1650 may extend along 50-90% of the length of each leg 1612, 1614. The reinforcing member 1674 extends along the bridge 1656 and optionally part way along the legs 1662, 1664. The reinforcing member 1674 may extend along 50-90% of the length of each leg 1662, 1664. The reinforcing members 1650, 1674 may be partially or wholly embedded in the bridges 1606, 1656 and the legs 1612, 1614, 1662, 1664 of the staple 1600, or they may be attached to the surface of the bridges 1606, 1656 and the legs 1612, 1614, 1662, 1664. The staple 1600 may include a base member 1652, which in this example is the polymer portion of the staple 1600 other than the reinforcing members 1650, 1674. The base member 1652 may be easily molded with the desired three-dimensional characteristics for the staple 1600. In this example, the base member 1652 includes a front channel 1654 that receives the reinforcing member 1650, and a back channel 1678 that receives the reinforcing member 1674. The staple 1600 may be referred to as a hybrid staple 1600 because it includes a polymer base member 1652 and metal reinforcing members 1650, 1674.

The staple 1600 is shown in its free state, in which the staple 1600 is not elastically or plastically deflected or deformed. The free state may be referred to as the closed state. In one example of the free state, the staple 1600 experiences no external loads, other than gravity perhaps. However, in the free state, the staple 1600 may experience loads that are below a threshold for elastic or plastic deflection or deformation. In the free state, the distal ends 1618, 1622, 1668, 1672 of the legs 1612, 1614, 1662, 1664 are closer together than the proximal ends 1616, 1620, 1666, 1670 so that the legs 1612, 1614, 1662, 1664 converge as they extend away from the bridges 1606, 1656. The reinforcing members 1650, 1674 may maintain the legs 1612, 1614, 1662, 1664 in the free state.

The staple 1600 may be moved between the free state and an elastically deformed state by elastically deforming some or all of the staple 1600, including corresponding portions of the reinforcing members 1650, 1674. For example, elastically deflecting or pressing on the bridge 1606 so that it is straight or curves down between the legs 1612, 1614 causes the distal ends 1618, 1622 to spread apart. The legs 1612, 1614 may spread apart in the elastically deformed state so as to become parallel. Similar manipulations may be made to the bridge 1656 and legs 1662, 1664. The elastically deformed state may be referred to as the open state. The elastically deformed state may be suitable for implantation of the staple 1600 and may thus be referred to as an insertion state or an implantation state. The reinforcing members 1650, 1674 may urge the base member 1652 from the elastically deformed state toward the free state and may increase the post-implantation compressive force of the staple 1600 compared to unreinforced polymer staples.

The staples 1500, 1600 and other staples with three or more legs according to the principles disclosed herein may be included in a suitably modified delivery device, preferably by including a connection for each leg of the staple, wherein the connections may be ruptured after the staple has been implanted as described above.

The delivery devices 100, 300, 500, 600, 700, 800 and staples 102, 302, 502, 602, 702, 802, 900, 1100, 1300, 1400, 1500, 1600 disclosed herein may be provided in packaging, preferably sterile packaging. The packaging may include a delivery device, a staple, and/or an inserter 104, 304, 504, 604, 704, 804. Optionally, the packaging may include a drill guide corresponding to the staple. The drill guide may optionally be provided as a part of the inserter which can be broken off from the inserter for independent use during surgery.

Referring to FIGS. 17A-17C, a system 1700 includes an implant 1800 and an inserter 1900. The system 1700 may be referred to as a delivery device and the inserter 1900 may be referred to as a delivery member. The implant 1800 is shown coupled to the inserter 1900, with the implant and inserter in their free states. The illustrated implant 1800 is a compression bone staple.

Referring to FIGS. 18A-18B, the implant 1800 includes bone engaging members 1802, 1804 which may be integral to an implant bridge 1806, also referred to as an implant body. The bone engaging members 1802, 1804 may be referred to as legs. The bone engaging member 1802 extends from a left end 1830 of the implant bridge 1806 and the bone engaging member 1804 extends from an opposite right end 1832 of the implant bridge 1806. Bone engaging member 1802 has a proximal end 1834 attached to the left end 1830 of the implant bridge 1806 and an opposite distal end 1836 which is a free end. Bone engaging member 1804 has a proximal end 1838 attached to the right end 1832 of the implant bridge 1806 and an opposite distal end 1840 which is a free end. Implant bridge 1806 has an upper surface 1808, a lower surface 1810, a front surface 1809, and an opposite back surface (not shown). The lower surface 1810 may be referred to as a bone facing surface. Bone engaging member 1802 extends from the lower surface 1810 beside bone engaging member 1804. The bone engaging members 1802, 1804 may have features 1812 that may improve bone purchase or improve pull out strength of the implant 1800 from bone or soft tissue. The features 1812 may be referred to as teeth or serrations. The features 1812 are shown on facing sides of the bone engaging members 1802, 1804 but may be on any or all sides of the bone engaging members. The implant 1800 may have projections or other connecting means 1814, 1816 for connection with a means of insertion, such as inserter 1900. The connecting means 1814, 1816 may be referred to as tabs, ears, protrusions, retainers, wings, or retaining members. The connecting means 1814, 1816 are shown extending sideways outwardly from the ends 1830, 1832 of the bridge 1806, respectively, along a longitudinal direction established by the bridge. However, in other examples, the connecting means may extend outwardly from the ends 1830, 1832 of the bridge 1806, respectively, along a front to back direction. These examples may include four connecting means: left front, left back, right front, and right back. The connecting means 1814, 1816 may have lower surfaces 1818, 1820 respectively that may releasably engage with a means of insertion that may allow the inserter 1900 or other means of insertion to be side loading, top loading or pivotably loaded. For example, the inserter 1900 may be described as side loading or pivotably loading. The lower surfaces 1818, 1820 may be referred to as bone facing surfaces. Referring to FIG. 18A, the lower surfaces 1818, 1820 are proximally spaced apart from, or proximally offset from, from the lower surface 1810. The dashed extension lines 1810′, 1810″ in FIG. 18A show the level) of the lower surface 1810 versus the lower surfaces 1818, 1820.

The means of insertion may maintain a one piece implant in a first configuration thereby allowing a second implant configuration once the implant is disassembled from the implant. The first configuration may be an elastically deformed state, for example an insertion state. The second configuration may be a free state or an implanted state. The means of insertion may utilize features similar to connecting means 1814 and 1816 in combination with other surfaces such as top surface 1808. This combination of means of insertion may be used to maintain one or more features or arms or projections in a particular configuration. This combination of means of insertion may create a bending modality, such as a three point or four point bend, to maintain a specific implant configuration or combination of configurations. A combination of surfaces and means of insertion, such as connecting means 1814, may be used on the entire implant or portions of an implant to create or maintain a particular configuration of an implant. For example, a tab such as 1814 and top surface, such as 1808 may be used to maintain one side of an implant or one arm of an implant in a particular configuration. When disassembled, that arm may have a configuration that is different from or the same as the configuration of the rest of the implant.

Referring to FIGS. 18A-18B, the implant 1800 is shown uncoupled from the inserter 1900. The implant 1800 is in a free state, or relaxed state, which is the shape of the implant 1800 when no external forces are acting upon the implant 1800, other than gravity; the implant 1800 experiences no elastic or plastic deflection or deformation. In the free state, the bone engaging members 1802, 1804 converge as they extend away from the bridge 1806 so that the distal ends 1836, 1840 are closer together than are the proximal ends 1834, 1838. An angle 1822 is formed between the converging bone engaging members 1802, 1804 in the free state. The angle 1822 opens toward the bridge 1806. The angle 1822 may be referred to as a free state angle.

Referring to FIGS. 19A-19B, another implant 1850 may be included in the system 1700 instead of implant 1800. The implant 1850 may be identical to the implant embodiment 2200 described in International Patent Application Serial No. PCT/US2015/039551.

Referring to FIGS. 19A-19B, the implant 1850 includes bone engaging members 1852, 1854 which may be integral to an implant bridge 1856, also referred to as an implant body. The bone engaging members 1852, 1854 may be referred to as legs. The bone engaging member 1852 extends from a left end 1880 of the implant bridge 1856 and the bone engaging member 1854 extends from an opposite right end 1882 of the implant bridge 1856. Bone engaging member 1852 has a proximal end 1884 attached to the left end 1880 of the implant bridge 1856 and an opposite distal end 1886 which is a free end. Bone engaging member 1854 has a proximal end 1888 attached to the right end 1882 of the implant bridge 1856 and an opposite distal end 1890 which is a free end. Implant bridge 1856 has an upper surface 1858, a lower surface 1860, a front surface 1859, and a back surface (not shown). The lower surface 1860 may be referred to as a bone facing surface. Bone engaging member 1852 extends from the lower surface 1860 beside bone engaging member 1854. The bone engaging members 1852, 1854 may have features 1862 that may improve bone purchase or improve pull out strength of the implant 1850 from bone or soft tissue. The features 1862 may be referred to as teeth or serrations. The features 1862 are shown on facing sides of the bone engaging members 1852, 1854 but may be on any or all sides of the bone engaging members. The implant 1850 may have projections or other connecting means 1864, 1866 for connection with a means of insertion, such as inserter 1900. The connecting means 1864, 1866 may be referred to as tabs, ears, protrusions, retainers, wings, or retaining members. The connecting means 1864, 1866 are shown extending sideways outwardly from the ends 1880, 1882 of the bridge 1856, respectively, along a longitudinal direction established by the bridge. However, in other examples, the connecting means may extend outwardly from the ends 1880, 1882 of the bridge 1856, respectively, along a front to back direction. These examples may include four connecting means: left front, left back, right front, and right back. The connecting means 1864, 1866 may have lower surfaces 1868, 1870 respectively that may releasably engage with a means of insertion that may allow the inserter 1900 or other means of insertion to be side loading, top loading or pivotably loaded. For example, the inserter 1900 may be described as side loading or pivotably loading. The lower surfaces 1868, 1870 may be referred to as bone facing surfaces. Referring to FIG. 19A, the lower surfaces 1868, 1870 are proximally spaced apart from, or proximally offset from, from the lower surface 1860. The dashed extension lines 1860′, 1860″ in FIG. 19A show the level) of the lower surface 1860 versus the lower surfaces 1868, 1870.

The means of insertion may maintain a one piece implant in a first configuration thereby allowing a second implant configuration once the implant is disassembled from the implant. The first configuration may be an elastically deformed state, for example an insertion state. The second configuration may be a free state or an implanted state. The means of insertion may utilize features similar to connecting means 1864 and 1866 in combination with other surfaces such as top surface 1858. This combination of means of insertion may be used to maintain one or more features or arms or projections in a particular configuration. This combination of means of insertion may create a bending modality, such as a three point or four point bend, to maintain a specific implant configuration or combination of configurations. A combination of surfaces and means of insertion, such as connecting means 1864, may be used on the entire implant or portions of an implant to create or maintain a particular configuration of an implant. For example, a tab such as 1864 and top surface, such as 1858 may be used to maintain one side of an implant or one arm of an implant in a particular configuration. When disassembled, that arm may have a configuration that is different from or the same as the configuration of the rest of the implant.

Referring to FIGS. 19A-19B, the implant 1850 is shown uncoupled from the inserter 1900. The implant 1850 is in a free state, or relaxed state, which is the shape of the implant 1850 when no external forces are acting upon the implant 1850, other than gravity; the implant 1850 experiences no elastic or plastic deflection or deformation. In the free state, the bone engaging members 1852, 1854 converge as they extend away from the bridge 1856 so that the distal ends 1886, 1890 are closer together than are the proximal ends 1884, 1888. An angle 1872 is formed between the converging bone engaging members 1852, 1854 in the free state. The angle 1872 opens toward the bridge 1856. The angle 1872 may be referred to as a free state angle.

The implants 1800, 1850 may be fabricated from any suitably elastic biocompatible material. The implants 1800, 1850 are preferably made of metal or polymer, preferably nitinol or polyetheretherketone (PEEK).

Referring to FIGS. 17A-17C and 20A-20B, the inserter 1900 includes a body 2000, a first arm 2060, and a second arm 2070. The first and second arms 2060, 2070 are separate component parts in this example, however the first and second arms 2060, 2070 may optionally be integrally formed with the body 2000 as a single part.

The illustrated inserter 1900 has a first plane of symmetry along plane 1 of FIG. 17A and a second plane of symmetry along plane 2 of FIG. 17B, which is shown edge on and is thus represented by a line 2. The first and second planes of symmetry are perpendicular to each other. The first plane of symmetry divides the inserter 1900 into left and right halves. The second plane of symmetry divides the inserter 1900 into front and back halves. The first and second planes of symmetry also apply to the implant 200 and the body 2000. However, in other examples, the inserter 1900 and/or implant 200 may have only one plane of symmetry, or no plane of symmetry so that they are asymmetric.

The body 2000 is an elongated part that extends between a distal end 2002 and an opposite proximal end 2004. The distal end 2002 may be referred to as a working portion and the proximal end 2004 may be referred to as a handle. The body 2000 has a front surface 2006, an opposite back surface 2008, a left side 2010, and an opposite right side 2012. The body 2000 includes a left half 2018 and a right half 2020. The left and right halves 2018, 2020 may be mirror images of each other, except for the clip features discussed below. The left half 2018 has a distal portion 2022 and a proximal portion 2024. The right half 2020 has a distal portion 2026 and a proximal portion 2028.

The left and right halves 2018, 2020 may be joined together by an optional flex bridge 2032, which biases the proximal portions 2024, 2028 away from each other. The flexible bridge 2032 is shown with a bend to enhance flexibility of the flex bridge. The flex bridge 2032 may be replaced by another type of biasing element, such as a spring. The flex bridge 2032 is shown integral with the body 2000, but the flex bridge may be a separate component part, for example a metal ribbon coupled to the left and right halves 2018, 2020.

The distal portions 2022, 2026 may be joined together at a central junction 2030. The junction 2030 may be referred to as an intermediate connection. The body 2000 includes a left arm recess 2014 and a right arm recess 2016. The left arm recess 2014 extends into the left side 2010 at the distal end 2002. The right arm recess 2016 extends into the right side 2012 at the distal end 2002. The right arm recess 2016 is a mirror image of the left arm recess 2014 in this example. When the first and second arms 2060, 2070 are integrally formed with the body 2000, the arm recesses 2014, 2016 are not present.

The proximal portions 2024, 2028 may be enlarged and rounded to form comfortable handles for a user to grasp. The left proximal portion 2024 may optionally include a first clip feature 2034 and the right proximal portion 2028 may optionally include a second clip feature 2036. The first and second clip features 2034, 2036 cooperate to releasably hold the left proximal portion 2024 at a fixed distance from the right proximal portion 2028. The first clip feature 2034 includes a recess 2038 that receives and releasably retains a tooth 2040 included in the second clip feature 2036. Multiple recesses and/or teeth may be included to provide multiple different fixed distances between the proximal portions 2024, 2028. The engagement between the recess 2038 and the tooth 2040 may be released by actuating a lever 2042 or other control feature. The lever 2042 is shown included in the second clip feature 2036 but can instead be included in the first clip feature 2036. The first and second clip features 2034, 2036 may be integral with the body 2000 as shown, or optionally may be separate component parts coupled to the left and right halves 2018, 2020. The clip features 2034, 2036 shown may be replaced with a ratchet mechanism or other releasable retention mechanism.

The first arm 2060 is an elongated part that extends between a distal end 2061 and an opposite proximal end 2062. The first arm 2060 has a front surface 2063, an opposite back surface 2064, an outer side 2065, and an opposite inner side 2066. The distal end 2061 may be referred to as a jaw or a connection. The distal end 2061 terminates in a small hook 2067 that protrudes from the inner side 2066. The hook 2067 may be referred to as a formation, a clip (distinct from the first and second clip features 2034, 2036), a connection, or a capture member.

The second arm 2070 in this example is identical to the first arm 2060. However, to differentiate the two parts, the second arm is given reference number series 2070.

The second arm 2070 is an elongated part that extends between a distal end 2071 and an opposite proximal end 2072. The second arm 2070 has a front surface 2073, an opposite back surface 2074, an outer side 2075, and an opposite inner side 2076. The distal end 2071 may be referred to as a jaw or a connection. The distal end 2071 terminates in a small hook 2077 that protrudes from the inner side 2076. The hook 2077 may be referred to as a formation, a clip (distinct from the first and second clip features 2034, 2036), a connection, or a capture member.

The body 2000 may be fabricated from any suitable material. The body 2000 is preferably made of metal or polymer, preferably stainless steel or polycarbonate. The first and second arms 2060, 2070 may be fabricated from any suitable material. The first and second arms 2060, 2070 are preferably made of metal or polymer, preferably stainless steel or polycarbonate. In one example, the body 2000 is made of a polymer and the first and second arms 2060, 2070 are made of hardened steel. In another example, the body 2000 and the arms 2060, 2070 are integrally formed as a single part made of metal, preferably an elastic metal such as spring steel. In yet another example, the body 2000 and the arms 2060, 2070 are integrally formed as a single part made of polymer.

The first arm 2060 is coupled to the body 2000 so that the distal end 2002 and the distal end 2061 face the same direction, the front surface 2006 and the front surface 2063 face the same direction, the back surface 2008 and the back surface 2064 face the same direction, and the inner side 2066 faces into the left arm recess 2014. The second arm 2070 is coupled to the body 2000 so that the distal end 2002 and the distal end 2071 face the same direction, the front surface 2006 and the back surface 2074 face the same direction, the back surface 2008 and the front surface 2073 face the same direction, and the inner side 2076 faces into the right arm recess 2016. When the first and second arms 2060, 2070 are coupled to the body 2000, the concave sides of the hooks 2067, 2077 face each other. The first and second arms 2060, 2070 may be coupled to the body 2000 by screws, pins, rivets, press fit, dovetail connection, adhesive, over molding, insert molding, or other means. Preferably, the first and second arms 2060, 2070 are rigidly coupled to the body 2000, and are removable for cleaning or replacement. As mentioned previously, the first and second arms 2060, 2070 may optionally be integrally formed with the body 2000 as a single part.

When the inserter 1900 is fully assembled as shown in FIG. 17C, as the proximal portions 2024, 2028 are moved toward each other, the left and right halves 2018, 2020 pivot about the central junction 2030 so that the hooks 2067, 2077 rotate proximally relative to the central junction 2030, the optional flex bridge 2032 deforms so that the proximal bend becomes more pronounced, and, if present, the first and second clip features 2034, 2036 move towards each other so that eventually the tooth 2040 is received in the recess 2038. The flex bridge preferably deforms elastically. When the proximal portions 2024, 2028 are pressed inwardly toward each other against the resistance of the flex bridge 2032, the inserter 1900 is in a compressed state, also referred to as an actuated state. When the tooth 2040 is received in the recess 2038, the inserter 1900 is in a locked state. If there are multiple recesses 2038 and/or teeth 2040, then when the first tooth/recess are engaged, the inserter 1900 is in a first locked state; when the second tooth/recess are engaged, the inserter 1900 is in a second locked state; and so on for third, fourth, or higher locked states. If present, the first and second clip features 2034, 2036 may be disengaged or released by pressing the lever 2042 toward the right proximal portion 2028. As the proximal portions 2024, 2028 are moved away from each other, the left and right halves 2018, 2020 pivot about the central junction 2030 so that the hooks 2067, 2077 rotate distally relative to the central junction 2030, the flex bridge 2032 relaxes so that the proximal bend becomes less pronounced, and, if present, the first and second clip features 2034, 2036 move away from each other. The proximal portions 2024, 2028 may be biased by the flex bridge 2032 to move away from each other automatically as soon as inward pressure on the proximal portions 2024, 2028 is released, or, if present, as soon as the first and second clip features 2034, 2036 are disengaged or released. When the first and second clip features 2034, 2036 are disengaged or released, the inserter 1900 is in an unlocked state. When the flex bridge 2032 has relaxed to its free state, the inserter 1900 is in a free state.

Referring to FIG. 17A-17C, the implant 1800 is shown coupled or connected to the inserter 1900. The implant 1800 and inserter 1900 are each in the free state. The implant 1800 is coupled to the inserter 1900 by engaging the hooks 2067, 2077 of the first and second arms 2060, 2070 under the connecting means 1814, 1816 of the implant 1800, for example by sliding or twisting. The inserter 1900 is secured to, for example, clips over, around, and/or underneath the retaining members of the implant 1800. With the bridge 1806 parallel to the second plane of symmetry as shown in FIGS. 17A-17C, the connecting means 1814, 1816 and the bridge 1806 may slide straight into engagement with the hooks 2067, 2077 from the front or back of the inserter 1900. Alternately, the hooks 2067, 2077 may slide under the connecting means 1814, 1816 along the longitudinal direction established by the bridge. Alternately, with the bridge parallel to the first plane of symmetry, the middle of the bridge 1806 may be placed adjacent to the central junction 2030 and the implant 1800 may be twisted clockwise or counterclockwise relative to the inserter 1900 to rotate the connecting means 1814, 1816 into engagement with the hooks 2067, 2077. When the implant 1800 is coupled to the inserter 1900, the distal) portions 2022, 2026 of the body 2000 extend along and above the bridge 1806 of the implant 1800 so that the central junction 2030 is adjacent to a middle portion of the bridge 1806. When the implant 1800 and inserter 1900 are each in the free state, the central junction 2030 is separated from the bridge 1806 by a gap 2031 (FIG. 17A). The proximal portions 2024, 2028 extend away from the bridge 1806 generally opposite the bone engaging members 1802, 1804. The implant 1800 may be pre-loaded on the inserter 1900 in a package, such as a sterile package, with the implant 1800 in the free state. The implant 1800 is also decoupled or disconnected from the inserter 1900 by disengaging the hooks 2067, 2077 of the first and second arms 2060, 2070 from under the connecting means 1814, 1816 of the implant 1800 by sliding or twisting. The connection between the inserter 1900 and the implant 1800 may be ruptured by changing the shape of the inserter 1900 and/or by twisting the inserter 1900 relative to the retaining members. The retaining members remain in place with the implant 1800 after the inserter 1900 has been removed.

Referring to FIGS. 17A, 17C, and 18A, when the implant 1800 is coupled to the inserter 1900, the hooks 2067, 2077 may not extend below the lower surface 1810 of the bridge 1806, due at least in part to the arrangement of the lower surfaces 1818, 1820 of the connecting means 1814, 1816 being proximally offset from the lower surface 1810 of the bridge 1806. Instead, the hooks 2067, 2077 may be even with, or flush with, the lower surface 1810; or proximally spaced apart from, or proximally offset from, the lower surface 1810. More specifically, the distal-most aspect of each hook 2067, 2077 may be at the same level as, or proximal to, the lower surface 1810. This is significant because the lower surface 1810 may contact a bone surface when the implant 1800 is implanted. In examples where the hooks 2067, 2077 are flush with, or proximally offset from, the lower surface, the implant 1800 may be fully seated against the bone surface without interference from the hooks 2067, 2077 against the bone surface. Referring to FIG. 18A, the dashed extension lines 1810′, 1810″ show the level of the lower surface 1810 when the implant 1800 is in the free state. FIGS. 17A, 17C, and 18A also illustrate that the bridge 1806, connecting means 1814, 1816, and the entire inserter 1900 are located on the proximal side of the lower surface 1810.

Referring to FIGS. 17A-17C, when the implant 1800 is coupled to the inserter 1900, the inserter 1900 may be actuated to urge the implant 1800 into an elastically deformed state. The inserter 1900 may be moved from the free state to the compressed state, or the locked state if the first and second clip features 2034, 2036 are present (or to a first, second, or higher locked state if multiple locked states are enabled by the design of the inserter 1900). As the inserter 1900 moves from the free state to the compressed state or the locked state, the hooks 2067, 2077 rotate proximally relative to the central junction 2030 and the gap 2031 (FIG. 17A) decreases until the central junction 2030 contacts the upper surface 1808 of the bridge 1806 and presses the bridge distally against the resistance of the hooks 2067, 2077 under the connecting means 1814, 1816. In the example, the central junction 2030 contacts and pushes against the middle of the upper surface 1808 to put the bridge into three point bending. However, the central junction 2030 may be designed to contact and push against a different location along the upper surface 1808, or multiple locations. A central junction designed to contact two separate locations along the upper surface 1808 would put the bridge into four point bending, for example. While in the illustrated example, the proximal portions 2024, 2028 are moved toward each other to actuate the inserter 1900, in other examples the proximal portions 2024, 2028 may be moved away from each other, or otherwise moved relative to each other, to actuate the inserter 1900.

Actuating the inserter 1900 from the free state to the compressed state or the locked state puts the implant 1800 into an elastically deformed state in which the distal ends 1836, 1840 of the bone engaging members 1802, 1804 are farther away from each other than they are in the implant free state. The inserter 1900 may urge the implant 1800 into a first elastically deformed state in which the distal ends 1836, 1840 are farther apart than they are in the implant free state, but not as far apart as the proximal ends 1834, 1838, so that the bone engaging members 1802, 1804 still converge slightly; a second elastically deformed state in which the distal ends 1836, 1840 and the proximal ends 1834, 1838 are the same distance apart, so that the bone engaging members 1802, 1804 are parallel, at least to the unaided eye; or a third elastically deformed state in which the distal ends 1836, 1840 are farther apart than are the proximal ends 1834, 1838, so that the bone engaging members 1802, 1804 diverge.

As the inserter 1900 moves from the compressed state or the locked state to the free state, the hooks 2067, 2077 rotate distally relative to the central junction 2030 and the central junction 2030 moves away from the upper surface 1808 of the bridge 1806 to allow the bridge 1806 and the entire implant 1800 to relax toward the implant free state.

The implant 1800 may be decoupled or disconnected from the inserter 1900 when the implant 1800 is in the free state or an elastically deformed state. The inserter 1900 may be decoupled or disconnected from the implant 1800 when the inserter 1900 is in the free state, the unlocked state, the compressed state, or a locked state if the first and second clip features 2034, 2036 are present.

A surgical method for stabilizing first and second bone fragments may include any or all of the following steps in any order: preparing a first hole in the first bone fragment; inserting a temporary fixation pin in the first hole; preparing a second hole in the second bone fragment; determining an implant size corresponding to the first and second holes; selecting the proper size implant 1800; coupling the selected implant 1800 to the inserter 1900, the implant 1800 in the free state; urging the implant 1800 into an elastically deformed state; inserting the bone engaging member 1802 into the first hole and the bone engaging member 1804 into the second hole; seating the lower surface 1810 against a surface of the first or second bone fragment; allowing the implant 1800 to relax toward the implant free state; and decoupling the inserter 1900 from the implant 1800. Allowing the implant 1800 to relax toward the implant free state may comprise releasing inward pressure on the proximal portions 2024, 2028. Optionally, allowing the implant 1800 to relax toward the implant free state may comprise disengaging the first and second clip features 2034, 2036.

Referring to FIGS. 21A-25D, another system 2100 includes an implant 2200 and an inserter 2300. The system 2100 may be referred to as a delivery device and the inserter 2300 may be referred to as a delivery member. In FIGS. 21A-21B, the implant 2200 is shown coupled to the inserter 2300, with the implant 2200 and inserter 2300 in their free states. The illustrated implant 2200 is a compression bone staple.

Referring to FIGS. 21A-21B and 25A-25D, the implant 2200 includes bone engaging members 2202, 2204 which may be integral to an implant bridge 2206, also referred to as an implant body. The bone engaging members 2202, 2204 may be referred to as legs. The bone engaging member 2202 extends from a left end 2230 of the implant bridge 2206 and the bone engaging member 2204 extends from an opposite right end 2232 of the implant bridge 2206. Bone engaging member 2202 has a proximal end 2234 attached to the left end 2230 of the implant bridge 2206 and an opposite distal end 2236 which is a free end. Bone engaging member 2204 has a proximal end 2238 attached to the right end 2232 of the implant bridge 2206 and an opposite distal end 2240 which is a free end. Implant bridge 2206 has an upper surface 2208, a lower surface 2210, a front surface 2209, and a back surface 2211. The lower surface 2210 may be referred to as a bone facing surface. Bone engaging member 2202 extends from the lower surface 2210 beside bone engaging member 2204. The bone engaging members 2202, 2204 may have features 2212 that may improve bone purchase or improve pull out strength of the implant 2200 from bone or soft tissue. The features 2212 may be referred to as teeth or serrations. The features 2212 are shown on facing sides of the bone engaging members 2202, 2204 but may be on any or all sides of the bone engaging members.

The implant 2200 may have projections or other connecting means 2214, 2216 for connection with a means of insertion, such as inserter 2300. The connecting means 2214, 2216 may be referred to as tabs, ears, protrusions, retainers, wings, or retaining members. The connecting means 2214, 2216 are shown extending outwardly from the front surface 2209 from the ends 2230, 2232 of the bridge 2206, respectively, along a front to back direction established between the front surface 2209 and the back surface 2211. This example also includes connecting means 2215, 2217 which are identical to connecting means 2214, 2216, respectively, but which extend outwardly from the back surface 2211 from the ends 2230, 2232 of the bridge 2206, respectively, along the front to back direction. Connecting means 2215 is not visible. The connecting means 2214, 2215, 2216, 2217 have surfaces 2218, 2219, 2220, 2221 respectively. Surface 2219 is not visible. The surfaces 2218, 2219, 2220, 2221 may releasably engage with a means of insertion that may allow the inserter 2300 or other means of insertion to be side loading, top loading, pivotably loaded, or end loading. For example, the inserter 2300 may be described as end loading. The surfaces 2218, 2219, 2220, 2221 may be referred to as bone facing surfaces since they angle outwardly and face distally. Referring to FIGS. 21B and 25D, the surfaces 2218, 2219, 2220, 2221 are proximally spaced apart from, or proximally offset from, from the surface 2210. The dashed extension lines 2210′, 2210″ in FIGS. 25C-25D show the level) of the surface 2210 versus the surfaces 2218, 2220, 2221. In this example, connecting means 2214 and surface 2218 extend across the bridge 2206 toward the right end 2232 to merge with connecting means 2216 and surface 2220. Likewise, connecting means 2217 and surface 2221 extend across the bridge 2206 toward the left end 2230 to merge with connecting means 2215 and surface 2219. Taken together, the connecting means 2214, 2215, 2216, 2217 and surfaces 2218, 2219, 2220, 2221 form a dovetail rail 2213 that extends completely across the bridge 2206 from left to right. However, in other examples, the connecting means 2214, 2215, 2216, 2217 may be discrete features.

Referring to FIGS. 25A-25B, the implant 2200 includes an optional reinforcing member 2250 which may be metal, for example a nickel titanium alloy. When the implant 2200 includes the reinforcing member, the implant may also include a base member 2252, which in this example is the polymer portion of the implant 2200 other than the reinforcing member 2250. The polymer may be PEEK. The base member 2252 may be easily molded with the desired three-dimensional characteristics for the implant 2200. The base member 2252 may include an optional channel 2254 into which the optional reinforcing member 2250 is fitted. The implant 2200 may be referred to as a hybrid implant 2200 because it includes a polymer base member 2252 and a metal reinforcing member 2250. Alternatively, the implant 2200 may lack the reinforcing member 2250 and the channel 2254.

The means of insertion may maintain a one piece implant in a first configuration thereby allowing a second implant configuration once the implant is disassembled from the implant. The first configuration may be an elastically deformed state, for example an insertion state. The second configuration may be a free state or an implanted state. The means of insertion may utilize features similar to connecting means 2214 and 2216 in combination with other surfaces such as top surface 2208. This combination of means of insertion may be used to maintain one or more features or arms or projections in a particular configuration. This combination of means of insertion may create a bending modality, such as a three point or four point bend, to maintain a specific implant configuration or combination of configurations. A combination of surfaces and means of insertion, such as connecting means 2214, may be used on the entire implant or portions of an implant to create or maintain a particular configuration of an implant. For example, a protrusion such as 2214 and top surface, such as 2208 may be used to maintain one side of an implant or one arm of an implant in a particular configuration. When disassembled, that arm may have a configuration that is different from or the same as the configuration of the rest of the implant.

Referring to FIGS. 25A-25D, the implant 2200 is shown uncoupled from the inserter 2300. The implant 2200 is in a free state, or relaxed state, which is the shape of the implant 2200 when no external forces are acting upon the implant 2200, other than gravity; the implant 2200 experiences no elastic or plastic deflection or deformation. In the free state, the bone engaging members 2202, 2204 converge as they extend away from the bridge 2206 so that the distal ends 2236, 2240 are closer together than the proximal ends 2234, 2238. An angle 2222 is formed between the converging bone engaging members 2202, 2204 in the free state. The angle 2222 opens toward the bridge 2206. The angle 2222 may be referred to as a free state angle.

The implant 2200 may be fabricated from any suitably elastic biocompatible material. The implant 2200 is preferably made of metal or polymer, preferably nitinol or polyetheretherketone (PEEK).

Referring to FIGS. 21A-24 , the inserter 2300 includes a body 2400, a left capture member 2500, a right capture member 2600, and a control member 2700. The capture members 2500, 2600 are separate component parts in this example, however the capture members 2500, 2600 may optionally be integrally formed with the body 2400 as a single part.

The illustrated inserter 2300 has a first plane of symmetry along plane 11 of FIG. 21A, which is shown edge on in FIG. 21B and is thus represented by a line 11. The inserter 2300 may have a second plane of symmetry along plane 12, which is shown edge on in FIG. 25D and is thus represented by a line 12. The first and second planes of symmetry are perpendicular to each other. The first plane of symmetry divides the inserter 2300 into left and right halves. The second plane of symmetry divides the inserter 2300 into front and back halves. The first and second planes of symmetry also apply to the implant 200, the optional reinforcing member 2250, the base member 2252, the body 2400, and the control member 2700. However, in other examples, the inserter 2300 and/or implant 200 may have only one plane of symmetry, or no plane of symmetry so that they are asymmetric.

Referring to FIGS. 21A-22B, the body 2400 is an elongated part that extends between a distal end 2402 and an opposite proximal end 2404. The distal end 2402 may be referred to as a working portion and the proximal end 2404 may be referred to as a handle. The body 2400 has a front surface 2406, an opposite back surface 2408, a left side 2410, and an opposite right side 2412. The body 2400 includes a left half 2418 and a right half 2420. The left and right halves 2418, 2420 may be mirror images of each other, except for the clip features discussed below. The left half 2418 has a distal portion 2422 and a proximal portion 2424. The right half 2420 has a distal portion 2426 and a proximal portion 2428.

Referring to FIGS. 22A-22B, the left and right halves 2418, 2420 may be joined together by an optional flex bridge 2432, which may bias the proximal portions 2424, 2428 away from each other. The flexible bridge 2432 is shown with a bend which may enhance flexibility of the flex bridge. The flex bridge 2432 may be replaced by another type of biasing element, such as a spring. The flex bridge 2432 is shown integral with the body 2400, but the flex bridge may be a separate component part, for example a metal ribbon coupled to the left and right halves 2418, 2420. Alternatively, the bridge 2432 may have the same flexibility as any other part of the body. The flex bridge 2432 includes a control slot 2458 which may have one or more narrow portions 2460 at intermediate locations along the control slot. One intermediate narrow portion 2460 is shown in this example.

The distal portions 2422, 2426 may meet at a central junction 2430. The junction 2430 may be referred to as an intermediate connection. In this example, the distal portions 2422, 2426 overlap at the central junction 2430. The left distal portion 2422 includes a left control pocket 2462 in the shape of a proximally concave hook at the central junction 2430. The control pocket 2462 may include one or more narrow portions 2463 at locations along the control pocket. One proximal narrow portion 2463 is shown in this example. The right distal portion 2426 includes a right control pocket 2464 in the shape of a proximally concave hook at the central junction 2430. The control pocket 2464 may include one or more narrow portions 2465 at locations along the control pocket. One proximal narrow portion 2465 is shown in this example. The right control pocket 2464 overlaps in front of the left control pocket 2462. This arrangement may be reversed, and may be further modified to include three or more interdigitated control pockets.

The body 2400 includes a left recess 2414 and a right recess 2416. The left recess 2414 extends into the distal end 2402 in the left half 2418. The left recess 2414 includes a proximal wide portion 2450 and a distal narrow portion 2452. The right recess 2416 extends into the distal end 2402 in the right half 2420. The right recess 2416 includes a proximal wide portion 2454 and a distal narrow portion 2456. The left recess 2414 is identical to the right recess 2416 in this example. The recesses 2414, 2416 may be referred to as formations or pockets. The recesses 2414, 2416 are optional, and are present when the capture members 2500, 2600 are separate from the body 2400. When the capture members 2500, 2600 are integrally formed with the body 2400, the recesses 2414, 2416 are not present.

Referring to FIG. 21A, the proximal portions 2424, 2428 may be enlarged and rounded, or otherwise adapted to form comfortable handles for a user to grasp. The left proximal portion 2424 may optionally include a first clip feature 2434 and the right proximal portion 2428 may optionally include a second clip feature 2436. The first and second clip features 2434, 2436 cooperate to releasably hold the left proximal portion 2424 at a fixed distance from the right proximal portion 2428. The first clip feature 2434 includes a groove 2438 that receives and releasably retains a tooth 2440 included in the second clip feature 2436. Multiple grooves and teeth are included to provide a ratchet interconnection that provides multiple different fixed distances between the proximal portions 2424, 2428. The first and second clip features 2434, 2436 may be integral with the body 2400 as shown, or optionally may be separate component parts coupled to the proximal portions 2424, 2428. The clip features 2434, 2436 shown may be replaced with another releasable retention mechanism.

Referring to FIG. 24 , the left capture member 2500 has a distal end 2502, an opposite proximal end 2504, a front surface 2506, an opposite back surface 2508, a left side 2510, and an opposite right side 2512. The distal end 2502 may be referred to as a jaw or a connection. The distal end 2502 includes front and back walls 2522, 2524 which define a dovetail groove 2526 between the walls. Taken together, the walls 2522, 2524 and dovetail groove 2526 may be referred to as a formation, a clip (distinct from the first and second clip features 2434, 2436), a connection, or a capture member. The proximal end 2504 includes a locking member 2528 which in this example, when viewed from the front or back, is a proximally pointing triangular feature. A securing member 2530 extends between the locking member 2528 and the distal end 2502. The securing member 2530 is narrower left to right than the locking member 2528, so that bilateral undercuts are formed at the transition between the locking member and the securing member.

The right capture member 2600 in this example is identical to the left capture member 2500. However, to differentiate the two parts, the right capture member is given reference number series 2600.

The right capture member 2600 has a distal end 2602, an opposite proximal end 2604, a front surface 2606, an opposite back surface 2608, a left side 2610, and an opposite right side 2612. The distal end 2602 may be referred to as a jaw or a connection. The distal end 2602 includes front and back walls 2622, 2624 which define a dovetail groove 2626 between the walls. Taken together, the walls 2622, 2624 and dovetail groove 2626 may be referred to as a formation, a clip (distinct from the first and second clip features 2434, 2436), a connection, or a capture member. At the left side 2610, the walls 2622, 2624 include front and back tabs 2632, 2634, respectively, which protrude toward each other, thus narrowing the dovetail groove 2626 at the left side. The tabs are also present on the left capture member 2500 but are not visible in FIG. 24 ; the front tab 2532 is visible in FIG. 21A. The proximal end 2604 includes a locking member 2628 which in this example, when viewed from the front or back, is a proximally pointing triangular feature. A securing member 2630 extends between the locking member 2628 and the distal end 2602. The securing member 2630 is narrower left to right than the locking member 2628, so that bilateral undercuts are formed at the transition between the locking member and the securing member.

Referring to FIG. 23 , the control member 2700 has a distal end 2702, a proximal end 2704, a front surface 2606, and a back surface 2708. A front longitudinal element 2714 extends between the distal end 2702 and the proximal end 2704. A back longitudinal element 2716 extends between the distal end 2702 and the proximal end 2704 and is held spaced apart from the front longitudinal element 2714 by a distal stem 2718 and a proximal stem 2720. The stems 2718, 2720 extend in a front to back direction.

The body 2400, capture members 2500, 2600, and control member 2700 may be fabricated from any suitable material. The body 2400 is preferably made of metal or polymer, preferably stainless steel or polycarbonate. The capture members 2500, 2600 are preferably made of metal or polymer, preferably stainless steel or polycarbonate. The control member 2700 is preferably made of metal or polymer, preferably stainless steel or polycarbonate. In one example, the body 2400 and control member 2700 are made of a polymer and the capture members 2500, 2600 are made of hardened steel. In another example, the body 2400 and the arms 2500, 2600 are integrally formed as a single part made of metal, preferably an elastic metal such as spring steel. In yet another example, the body 2400 and the arms 2500, 2600 are integrally formed as a single part made of polymer.

Referring to FIG. 21A, when the inserter 2300 is operatively assembled, the left capture member 2500 is coupled to the body 2400 so that the distal ends 2402, 2502 face the same direction, the front surfaces 2406, 2506 face the same direction, and the left sides 2410, 2510 face the same direction. The wide portion 2450 of the left recess 2414 receives the locking member 2528 and the narrow portion 2452 receives at least a portion of the securing member 2530. The right capture member 2600 is coupled to the body 2400 so that the distal ends 2402, 2602 face the same direction, the front surface 2406 and the back surface 2608 face the same direction, and the right side 2412 and the left side 2610 face the same direction. The wide portion 2454 of the right recess 2416 receives the locking member 2628 and the narrow portion 2456 receives at least a portion of the securing member 2630 The recesses 2414, 2416 engage the bilateral undercuts so that tension may be applied to the capture members 2500, 2600 by the inserter 2300. The recesses 2414, 2416 may receive the securing members 2530, 2630 and locking members 2528, 2628 with a close fit or an interference fit, and may even be formed around the securing members 2530, 2630 and locking members 2528, 2628 (or vice versa) in a molding operation. When the capture members 2500, 2600 are coupled to the body 2400, the dovetail grooves 2526, 2626 are aligned with each other. The capture members 2500, 2600 may be coupled to the body 2400 by screws, pins, rivets, press fit, dovetail connection, adhesive, over molding, insert molding, or other means. Preferably, the capture members 2500, 2600 are rigidly coupled to the body 2400, and are removable for cleaning or replacement. As mentioned previously, the capture members 2500, 2600 may optionally be integrally formed with the body 2400 as a single part. The control member 2700 is coupled to the body 2400 by inserting the proximal stem 2720 in the control slot 2458, preferably proximally past the narrow portion(s) 2460, so that the front longitudinal element 2714 is adjacent to the front surface 2406 and the back longitudinal element 2716 is adjacent to the back surface 2408. Alternatively, the back longitudinal element 2716 may be adjacent to the front surface 2406 and the front longitudinal element 2714 may be adjacent to the back surface 2408. The distal stem 2718 may then be inserted into the control pockets 2462, 2464 by moving the control member 2700 distally, preferably so that the distal stem 2718 moves past the narrow portions 2463, 2465, preferably until the distal stem 2718 is fully distally seated in the control pockets 2462, 2464. When the distal stem 2718 is in the control pockets 2462, 2464, the proximal stem 2720 may be distally positioned in the control slot 2458 distal to at least a proximal one of the narrow portion(s) 2460, or distally spaced outside the control slot 2458.

When the inserter 2300 is fully assembled as shown in FIG. 21A, with the distal stem 2718 in the control pockets 2462, 2464, as the proximal portions 2424, 2428 are moved toward each other, the gap 2444 becomes smaller, the left and right halves 2418, 2420 pivot about the central junction 2430 so that the capture members 2500, 2600 rotate proximally relative to the central junction 2430, the optional flex bridge 2432 may deform so that the proximal bend becomes more pronounced, and, if present, the first and second clip features 2434, 2436 move towards each other so that eventually the tooth 2440 is received in the groove 2438. The flex bridge preferably deforms elastically. When the proximal portions 2424, 2428 are pressed inwardly toward each other against the resistance of the flex bridge 2432, the inserter 2300 is in a compressed state, also referred to as an actuated state. When the tooth 2440 is received in the groove 2438, the inserter 2300 is in a locked state. Since there are multiple grooves 2438 and teeth 2440 in this example, then when the first tooth/recess are engaged, the inserter 2300 is in a first locked state; when the second tooth/recess are engaged, the inserter 2300 is in a second locked state; and so on for third, fourth, or higher locked states. When the distal stem 2718 is in the control pockets 2462, 2464, the control member 2700 is in a first control position. When the inserter 2300 is connected to the implant 2200 and the control member 2700 is in the first control position, the inserter 2300 is captive to the implant 2200; the inserter 2300 cannot be disconnected from the implant 2200. When the inserter 2300 is not connected to the implant 2200 and the control member 2700 is in the first control position, the inserter cannot be connected to the implant 2200.

If present, the first and second clip features 2434, 2436 may be disengaged or released by the user after the implant 2200 is implanted. With the control member 2700 in the first control position, as the proximal portions 2424, 2428 are moved away from each other, the left and right halves 2418, 2420 pivot about the central junction 2430 so that the capture members 2500, 2600 rotate distally relative to the central junction 2430, the flex bridge 2432 relaxes so that the proximal bend becomes less pronounced, and, if present, the first and second clip features 2434, 2436 move away from each other. The proximal portions 2424, 2428 may be biased by the flex bridge 2432 to move away from each other automatically as soon as inward pressure on the proximal portions 2424, 2428 is released, or, if present, as soon as the first and second clip features 2434, 2436 are disengaged or released. When the first and second clip features 2434, 2436 are disengaged or released, the inserter 2300 is in an unlocked state. When the flex bridge 2432 has relaxed to its free state, the inserter 2300 is in a free state. In the free state, the proximal portions 2424, 2428 are separated by a gap 2444 having a free state dimension 2446.

With the inserter 2300 in the free state, the control member 2700 may be moved proximally to move the proximal stem 2720 into the control slot 2458, preferably past at least a distal one of the narrow portion(s) 2460, preferably until the proximal stem 2720 is fully proximally seated in the control slot 2458; and to move the distal stem 2718 out of the control pockets 2462, 2464, preferably proximally past the narrow portions 2463, 2465. When the distal stem 2718 is out of the control pockets 2462, 2464, the control member 2700 is in a second control position in which the inserter 2300 is connectable to, and disconnectable from, the implant 2200. The inserter 2300 may now be actuated to connect or disconnect the inserter 2300 and the implant 2200.

As the proximal portions 2424, 2428 are moved toward each other, the gap 2444 becomes smaller, the left and right halves 2418, 2420 pivot about the proximal stem 2720 so that the capture members 2500, 2600 rotate outwardly left and right, respectively, relative to the proximal stem 2720, and, if present, the first and second clip features 2434, 2436 move towards each other so that eventually the tooth 2440 is received in the groove 2438.

As the proximal portions 2424, 2428 are moved away from other, the gap 2444 becomes larger, the left and right halves 2418, 2420 pivot about the proximal stem 2720 so that the capture members 2500, 2600 rotate inwardly from left and right, respectively, relative to the proximal stem 2720, and, if present, the first and second clip features 2434, 2436 move away from each other.

Referring to FIGS. 21A-21B, the implant 2200 is shown coupled or connected to the inserter 2300. The implant 2200 and inserter 2300 are each in the free state. With the control member 2700 in the second control position, the implant 2200 may be coupled to the inserter 2300 by actuating the inserter 2300, engaging the dovetail grooves 2526, 2626 of the capture members 2500, 2600 to the connecting means 2214, 2215, 2216, 2217 of the implant 2200, for example by sliding, and spreading apart the proximal portions 2424, 2428 of the inserter 2300. The inserter 2300 is secured to, for example, clips over, around, and/or underneath the connecting means of the implant 2200. With the bridge 2206 parallel to the second plane of symmetry as shown in FIGS. 21A-21B, the dovetail grooves 2526, 2626 may slide straight into engagement with the connecting means 2214, 2215, 2216, 2217 along the longitudinal direction established by the bridge 2206. In the example shown, the dovetail grooves 2526, 2626 slide onto the dovetail rail 2213. When the implant 2200 is coupled to the inserter 2300, the distal portions 2422, 2426 of the body 2400 extend along and above the bridge 2206 of the implant 2200 so that the central junction 2430 is adjacent to a middle portion of the bridge 2206. When the implant 2200 and inserter 2300 are each in the free state, the central junction 2430 may contact the bridge 2206, or the central junction 142 may optionally be separated from the bridge by a gap 2431. The proximal portions 2424, 2428 extend away from the bridge 2206 generally opposite the bone engaging members 2202, 2204. The implant 2200 may be pre-loaded on the inserter 2300 in a package, such as a sterile package, with the implant 2200 in the free state.

With the control member 2700 in the second control position, the implant 2200 may be decoupled or disconnected from the inserter 2300 by actuating the inserter 2300, disengaging the dovetail grooves 2526, 2626 from the connecting means 2214, 2215, 2216, 2217 by sliding the dovetail grooves 2526, 2626 outwardly left and right. The connection between the inserter 2300 and the implant 2200 may be ruptured by changing the shape of the inserter 2300.

Referring to FIGS. 21A-21B, when the implant 2200 is coupled to the inserter 2300, the walls 2522, 2524, 2622, 2624 may not extend below the lower surface 2210 of the bridge 2206, due at least in part to the arrangement of the surfaces 2218, 2219, 2220, 2221 of the connecting means 2214, 2215, 2216, 2217 being proximally offset from the lower surface 2210 of the bridge 2206. Instead, the walls 2522, 2524, 2622, 2624 may be even with, or flush with, the lower surface 2210; or proximally spaced apart from, or proximally offset from, the lower surface 2210. More specifically, the distal-most aspect of each wall 2522, 2524, 2622, 2624 may be at the same level as, or proximal to, the lower surface 2210. This is significant because the lower surface 2210 may contact a bone surface when the implant 2200 is implanted. In examples where the walls 2522, 2524, 2622, 2624 are flush with, or proximally offset from, the lower surface 2210, the implant 2200 may be fully seated against the bone surface without interference from the walls 2522, 2524, 2622, 2624 against the bone surface. Referring to FIG. 25C, the dashed extension lines 2210′, 2210″ show the level of the lower surface 2210 when the implant 2200 is in the free state. FIG. 21B illustrates that the bridge 2206, connecting means 2214, 2215, 2216, 2217, and the entire inserter 2300 are located on the proximal side of the lower surface 2210.

Referring to FIGS. 21A-21B, when the implant 2200 is coupled to the inserter 2300, the inserter 2300 may be actuated to urge the implant 2200 into an elastically deformed state. The inserter 2300 may be moved from the free state to the compressed state, or to a first, second, or higher locked state if the first and second clip features 2434, 2436 are present. With the control member 2700 in the first control position, as the inserter 2300 moves from the free state to the compressed state or the locked state, the capture members 2500, 2600 rotate proximally relative to the central junction 2430 and the gap 2431 decreases until the central junction 2430 contacts the upper surface 2208 of the bridge 2206 and presses the bridge distally against the resistance of the dovetail grooves 2526, 2626 engaged with the connecting means 2214, 2215, 2216, 2217. The control member 2700 may press distally against the central junction 2430 as the inserter 2300 is actuated. In the example, the central junction 2430 contacts and pushes against the middle of the upper surface 2208 to put the bridge into three point bending. However, the central junction 2430 may be designed to contact and push against a different location along the upper surface 2208, or multiple locations. A central junction designed to contact two separate locations along the upper surface 2208 would put the bridge into four point bending, for example. While in the illustrated example, the proximal portions 2424, 2428 are moved toward each other to actuate the inserter 2300, in other examples the proximal portions 2424, 2428 may be moved away from each other, or otherwise moved relative to each other, to actuate the inserter 2300.

Actuating the inserter 2300 from the free state to the compressed state or the locked state puts the implant 2200 into an elastically deformed state in which the distal ends 2236, 2240 of the bone engaging members 2202, 2204 are farther away from each other than they are in the implant free state. The inserter 2300 may urge the implant 2200 into a first elastically deformed state in which the distal ends 2236, 2240 are farther apart than they are in the implant free state, but not as far apart as the proximal ends 2234, 2238, so that the bone engaging members 2202, 2204 still converge slightly; a second elastically deformed state in which the distal ends 2236, 2240 and the proximal ends 2234, 2238 are the same distance apart, so that the bone engaging members 2202, 2204 are parallel, at least to the unaided eye; or a third elastically deformed state in which the distal ends 2236, 2240 are farther apart than are the proximal ends 2234, 2238, so that the bone engaging members 2202, 2204 diverge.

As the inserter 2300 moves from the compressed state or the locked state to the free state, the capture members 2500, 2600 rotate distally relative to the central junction 2430 and the central junction 2430 moves away from the upper surface 2208 of the bridge 2206 to allow the bridge 2206 and the entire implant 2200 to relax toward the implant free state.

In this example, the implant 2200 may be decoupled or disconnected from the inserter 2300 when the implant 2200 is in the free state or an elastically deformed state. The inserter 2300 may be decoupled or disconnected from the implant 2200 when the inserter 2300 has been prepared for implant disconnection by moving the control member 2700 to the second control position.

A surgical method for stabilizing first and second bone fragments may include any or all of the following steps in any order: preparing a first hole in the first bone fragment; inserting a temporary fixation pin in the first hole; preparing a second hole in the second bone fragment; determining an implant size corresponding to the first and second holes; selecting the proper size implant 2200; coupling the selected implant 2200 to the inserter 2300, the implant 2200 in the free state; urging the implant 2200 into an elastically deformed state; inserting the bone engaging member 2202 into the first hole and the bone engaging member 2204 into the second hole; seating the lower surface 2210 against a surface of the first or second bone fragment; allowing the implant 2200 to relax toward the implant free state; and decoupling the inserter 2300 from the implant 2200. Allowing the implant 2200 to relax toward the implant free state may comprise releasing inward pressure on the proximal portions 2424, 2428. Optionally, allowing the implant 2200 to relax toward the implant free state may comprise disengaging the first and second clip features 2434, 2436.

Any methods disclosed herein includes one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified.

Reference throughout this specification to “an embodiment” or “the embodiment” means that a particular feature, structure or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the quoted phrases, or variations thereof, as recited throughout this specification are not necessarily all referring to the same embodiment.

Similarly, it should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, Figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment. Thus, the claims following this Detailed Description are hereby expressly incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims.

Recitation in the claims of the term “first” with respect to a feature or element does not necessarily imply the existence of a second or additional such feature or element. Elements recited in means-plus-function format are intended to be construed in accordance with 35 U.S.C. § 112 Para. 6. It will be apparent to those having skill in the art that changes may be made to the details of the above-described embodiments without departing from the underlying principles of the technology.

While specific embodiments and applications of the present technology have been illustrated and described, it is to be understood that the technology is not limited to the precise configuration and components disclosed herein. Various modifications, changes, and variations which will be apparent to those skilled in the art may be made in the arrangement, operation, and details of the methods and systems of the present technology disclosed herein without departing from the spirit and scope of the technology. 

1. A staple delivery device comprising: a staple comprising a bridge, a first leg, and a second leg, wherein the bridge extends between a first end and a second end, wherein the first leg extends transversely from the first end of the bridge and terminates in a first free end which is remote from the bridge, wherein the second leg extends transversely from the second end of the bridge and terminates in a second free end which is remote from the bridge, wherein the first free end is beside the second free end; and an inserter connected to the staple, wherein the inserter comprises a first body and a second body which is a mirror image of the first body, wherein the first body is connected to the first end of the bridge by a first connection, wherein the second body is connected to the second end of the bridge by a second connection, wherein the first and second bodies are joined together at a junction which is adjacent to the bridge opposite the first and second legs; wherein the inserter is disconnected from the staple by rupturing the first and second connections, wherein the first and second connections are ruptured by an action selected from the group consisting of cutting the first and second connections with a surgical wire cutter, cutting the first and second connections with scissors, cutting the first and second connections with a scalpel, breaking the first and second connections with a rupturing instrument, and breaking the first and second connections manually.
 2. The staple delivery device of claim 1, wherein the junction is configured to be pressed against the bridge of the staple.
 3. The staple delivery device of claim 1, wherein a thickness of an upper portion of each of the first and second legs is greater than a thickness of a lower portion of each of the first and second legs.
 4. The staple delivery device of claim 1, wherein the staple further comprises a reinforcing device.
 5. The staple delivery device of claim 4, wherein the reinforcing device is wholly or partially embedded in the bridge.
 6. The staple delivery device of claim 4, wherein the reinforcing device is made with a metal material.
 7. The staple delivery device of claim 1, wherein at least one of the staple and the inserter is made with a polymeric material.
 8. The staple delivery device of claim 1, wherein the inserter is made with a material that is not approved for implantation in a human body.
 9. The staple delivery device of claim 1, wherein the staple further comprises a first securing member and a second securing member, wherein the first securing member extends transversely from the first end of the bridge opposite the first leg, wherein the second securing member extends transversely from the second end of the bridge opposite the second leg, and wherein the first body comprises a first recess, and the second body comprises a second recess, wherein the first recess is configured to receive the first securing member to form a first connection, and the second recess is configured to receive the second securing member to form a second connection.
 10. The staple delivery device of claim 1, wherein the staple further comprises a third leg.
 11. A staple delivery device comprising: a staple comprising a bridge, a first leg, and a second leg, wherein the bridge extends between a first end and a second end, wherein the first leg extends transversely from the first end of the bridge and terminates in a first free end which is remote from the bridge, wherein the second leg extends transversely from the second end of the bridge and terminates in a second free end which is remote from the bridge, wherein the first free end is beside the second free end; and an inserter integrally formed as a single part with the staple, wherein the inserter comprises a first body and a second body which is a mirror image of the first body, wherein the first body is connected to the first end of the bridge by a first connection, wherein the second body is connected to the second end of the bridge by a second connection, wherein the first and second bodies are joined together at a junction which is adjacent to the bridge opposite the first and second legs; wherein the inserter is disconnected from the staple by rupturing the first and second connections, wherein the first and second connections are ruptured by an action selected from the group consisting of cutting the first and second connections with a surgical wire cutter, cutting the first and second connections with scissors, cutting the first and second connections with a scalpel, breaking the first and second connections with a rupturing instrument, and breaking the first and second connections manually.
 12. The staple delivery device of claim 11, wherein the junction is configured to be pressed against the bridge of the staple.
 13. The staple delivery device of claim 11, wherein a thickness of an upper portion of each of the first and second legs is greater than a thickness of a lower portion of each of the first and second legs.
 14. The staple delivery device of claim 11, wherein the staple further comprises a reinforcing device.
 15. The staple delivery device of claim 14, wherein the reinforcing device is wholly or partially embedded in the bridge.
 16. The staple delivery device of claim 14, wherein the reinforcing device is made with a metal material.
 17. The staple delivery device of claim 11, wherein at least one of the staple and the inserter is made with a polymeric material.
 18. The staple delivery device of claim 11, wherein the staple further comprises a third leg.
 19. A staple delivery device comprising: a staple comprising a bridge, a first leg, a second leg, a first securing member, and a second securing member, wherein the bridge extends between a first end and a second end, wherein the first leg extends transversely from the first end of the bridge and terminates in a first free end which is remote from the bridge, wherein the second leg extends transversely from the second end of the bridge and terminates in a second free end which is remote from the bridge, wherein the first free end is beside the second free end, wherein the first securing member extends transversely from the first end of the bridge opposite the first leg, wherein the second securing member extends transversely from the second end of the bridge opposite the second leg; and an inserter connected to the staple, wherein the inserter comprises a first body and a second body which is a mirror image of the first body, wherein the first body comprises a first recess, wherein the second body comprises a second recess, wherein the first recess receives the first securing member to form a first connection, wherein the second recess receives the second securing member to form a second connection, wherein the first and second bodies are joined together at a junction which is adjacent to the bridge opposite the first and second legs; wherein the inserter is disconnected from the staple by rupturing the first and second connections, wherein the first and second connections are ruptured by an action selected from the group consisting of cutting the first and second connections with a surgical wire cutter, cutting the first and second connections with scissors, cutting the first and second connections with a scalpel, breaking the first and second connections with a rupturing instrument, and breaking the first and second connections manually.
 20. The staple delivery device of claim 11, wherein the junction is configured to be pressed against the bridge of the staple. 